2.7/3.5MM DEPTH GAUGE 0 TO 60MM

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING THE UNIVERSAL SMALL FRAGMENT SET, THE LONG SKINNY METAL ASPECT OF THE COMPLAINED DEPTH GAUGE BROKE IN 2 PIECES NEAR THE TIP OF THE DEPTH GAUGE. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE NEAR THE TIP AND AFTER OPENING UP ANOTHER OF THE SAME DEPTH GAUGE, THE SURGERY CARRIED ON WITHOUT DELAY AND THE SURGERY FINISHED SUCCESSFULLY. THE COMPLAINED DEPTH GAUGE WAS DEEMED TO BE NO LONGER FUNCTIONAL AND WAS SUBSEQUENTLY DISCARDED. A REPLACEMENT IS REQUIRED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (b)(4).THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.H11 ADDITIONAL NARRATIVE:D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.