PLATE HOLDER ANGLED

Description of Event or Problem

IT WAS REPORTED THAT PL-HOLDER ANGL MALFUNCTIONED DURING AN INTRAPELVIC ACETABULAR PLATE INSERTION. THE INSERTION HANDLE DID NOT HOLD THE PLATE SECURELY, AND UPON INSPECTION, ONE OF THE TINES THAT SEATS INTO THE PLATE WAS FOUND TO BE BENT. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.

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.