6.25MM VS PLATE 4-HOLE LEFT

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. CORRECTED. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PLATE HAS SCRATCHES & DEFORMATIONS. THE FRACTURE OCCURRED NEAR THE BASE OF THE SIDE HOLE EYELET. THE PLATE¿S FRACTURE SURFACES ARE SEEN WITH POSSIBLE MULTIPLE 2-WAY BENDING OVERLOAD FRACTURES. THE FRACTURED PIECE¿S FRACTURE SURFACES SHOW SIMILAR ARTIFACTS, SUGGESTING PROBABLE 2-WAY BENDING OVERLOAD FRACTURES & LIKELY MULTIPLE ORIGINS. AN XRF SCAN CONFIRMED THE PLATE¿S COMPOSITION AS CONFORMING TO SPECIFICATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

CMP-(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORETED WHILE THE SURGEON WAS BENDING THE PLATE DURING A PROCEDURE, IT FRACTURED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN ALTERNATIVE PLATE. NO FRACTURED PIECES FELL INTO THE PATIENT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.