RIGIDFIX PLA 3.3 MM FEMORAL ST CROSS PIN KIT

Description of Event or Problem

THE SALES REP REPORTED THAT DURING AN ACL REPAIR THAT THE PIN GUIDES OF CUSTOMER'S RIGIDFIX ST 3.3 CROSS PIN KIT AND RIGIDFIX ST GUIDEFRAME WOULD BIND TOGETHER. THE SURGEON REPLACED THE CROSS PIN KIT 2 TIMES WITH THE SAME ISSUE. THE SALES REP REPORTED THAT THE GUIDEFRAME WAS FOUND TO BE WARPED AND BENT. THE SALES REP REPORTED THAT NO METAL SHAVINGS WERE CREATED. THE SURGEON COMPLETED THE PROCEDURE WITH A 4TH RIGIDFIX ST 3.3 CROSS PIN KIT AND A SECOND SAME TYPE GUIDEFRAME WITH NO PATIENT CONSEQUENCES. THERE WAS A 40 MINUTE DELAY IN THE PROCEDURE. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER OR AGE FOR THE GUIDEFRAME BUT REPORTED IT HAS SEEN HEAVY USE. SEE ASSOCIATED MED WATCH 1221934-2014-00518, 1221934-2014-00519, 1221934-2014-00521.

Additional Manufacturer Narrative

THE COMPLAINT DEVICE IS NOT BEING RETURNED AND THEREFORE A PHYSICAL EVALUATION CANNOT BE PERFORMED. FROM THE EVENT DETAILS PROVIDED, THE FAILURE OF THE DEVICES IN THIS COMPLAINT COULD NOT BE SPECIFICALLY DETERMINED AND A ROOT CAUSE CANNOT BE DISCERNED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THEREFORE, AT THIS POINT IN TIME, BASED ON THE COMPLAINT HISTORY, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.