PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE

Additional Manufacturer Narrative

DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT DURING A CALCANEAL FRACTURE REPAIR, A PERIOSTEAL ELEVATOR HANDLE BROKE IN TWO PIECES. THE ITEM WAS PLACED ON THE BACK TABLE AND A REPLACEMENT SET WAS OPENED AND GIVEN TO THE SURGEON TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY IN CASE, NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AND NO PATIENT HARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

Additional Manufacturer Narrative

AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: SALES CONSULTANT REPORTED THAT DURING A CALCANEAL FRACTURE REPAIR, A PERIOSTEAL ELEVATOR (399.40 LOT UNKNOWN) HANDLE BROKE IN TWO PIECES. THE ITEM WAS PLACED ON THE FIELD (BACK TABLE) AND A REPLACEMENT (A NEW SET WAS OPENED AND GIVEN TO THE SURGEON TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY IN CASE, NO ADDITIONAL MEDICATION INTERVENTION REQUIRED AND NO PATIENT HARM. THE COMPLAINT CONDITION IS CONFIRMED AS THE RETURNED DEVICE WAS RECEIVED WITH THE HANDLE BROKEN IN TWO AT THE CROSS-PIN. WHILE IT CANNOT BE DEFINITIVELY DETERMINED SINCE THE SPECIFIC CIRCUMSTANCES AT THE TIME OF THE BREAK ARE UNKNOWN, THE MOST PROBABLE ROOT CAUSE IS THE METHOD OF USE AND HANDLING OVER THE 13+ YEAR LIFESPAN. THIS INVESTIGATION SUMMARY IS APPROVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.