SUTURE CROCHET HOOK

Additional Manufacturer Narrative

(B)(4). DEVICE PRODUCT CODE: (B)(4). REPORT SOURCE: (B)(6). VISUAL EXAMINATION OF THE RETURNED PRODUCT DETERMINED THAT THE TIP OF CROCHET HOOK IS ACTUALLY FRACTURED AND TIP WAS NOT RETURNED. THE DEVICE IS ALMOST 4 YEARS OLD AND SHOWS SIGNS OF USE. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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.

Description of Event or Problem

IT WAS REPORTED DURING THE INSPECTION OF THE KIT THE TIP OF THE PRODUCT WAS DISCOVERED AS FRACTURED. IT IS UNKNOWN WHEN THE BREAK OCCURRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.