Model Number LAA1-065
Event Type Injury Patient Outcome Other,Required Intervention,Hospitalization
Manufacturer Narrative
The patient's femurs were implanted bilaterally with precice nails. A company representative reported that the patient's left femoral precice nail broke, approximately eight (
months after implantation. The patient had completed their lengthening treatment and was in the consolidation phase. The surgeon removed the patient's left precice nail and implanted a trauma nail, without incident. To date, the patient is doing fine. An evaluation of the returned device is in process. A dhr review for the device revealed that there were no deviations from the manufacturing process and that the device was released within specifications.
Event Description
A representative reported that a patient's left femoral precice nail broke after approximately eight (
months of implantation; the patient was implanted bilaterally with precice nails. The patient had completed their lengthening treatment and was in the consolidation phase when the left femoral nail allegedly broke.
another one
Model Number LAA1-065
Event Type Injury Patient Outcome Other,Required Intervention,Hospitalization
Manufacturer Narrative
The patient had completed their lengthening prescription and was in the consolidation phase; however, the patient was full weight bearing on the implanted leg, against her surgeon's orders. The patient's precice nail was removed and the patient was implanted with a trauma nail. To date, the patient is doing fine and has fully recovered. The device involved in the alleged incident has not been returned; therefore, no evaluation can be conducted. A dhr review revealed that there were no deviations from the manufacturing process and that the device was released within specifications. This incident occurred as a result of the patient being non-compliant.
Event Description
The distributor reported a patient's precice nail broke after approximately three (3) months of implantation. The patient was non-compliant and was full weight bearing on the implanted leg.
another one
Model Number P10.7-80B335
Event Type Injury Patient Outcome Other,Required Intervention,Hospitalization
Manufacturer Narrative
The patient's existing precice nail was removed and the patient was revised with a precice nail of a smaller diameter and shorter length. To date, the patient is doing fine. The 'instructions for use' state that two (2) proximal and two (2) distal locking screws are to be used to secure the precice nail into the patient's bone. In addition, the surgeon must use discretion when selecting the appropriate length precice nail for each patient and take into account each patient's anatomy. To date, the device involved in the alleged incident has not been returned; therefore, no evaluation can be conducted. A dhr review revealed that there were no deviations from the manufacturing process and that the device was released within specifications. No similar complaints have been received with regard to this lot. The current investigation results indicate that this incident occurred as a result of a user/technique related problem and was not due to a product malfunction.
Event Description
The distributor reported that the length chosen for a patient's precice nail was too long. Only one proximal locking screw and one distal locking screw was used to secure the precice nail. As a result, the distal locking screw was bending as the patient was lengthening.
Author
Topic: FDA PRECICE MALFUCTION LINK (Read 4396 times)