MULTILOC

Description of Event or Problem

IT WAS REPORTED THAT DURING USE, THE PROBE OF THE DEPTH GAUGE FELL OFF AND THE QUICK CONNECT WAS UNABLE TO OPEN AND LATCH ONTO THE SCREWDRIVER. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY.

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: H3, H6: PART NUMBER: 03.019.017-US. LOT NUMBER: 58743P4. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: 23.06.2025. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT THE HOOK BECAME DETACHED FROM THE BASE OF THE DEVICE BODY. NO ADDITIONAL ISSUES WERE OBSERVED; THEREFORE, THE REPORTED COMPLAINT CONDITION CAN BE CONFIRMED. BASED ON THE AVAILABLE EVIDENCE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DEPTH GAUGE F/MULTILOC HUM NAIL SYST WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.