UNK - PLATES: TRAUMA

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 CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. E3: INITIAL REPORTER OCCUPATION: LAWYER.

Description of Event or Problem

IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2022, THE PATIENT FELL AT HER HOME AND FRACTURED HER LEFT WRIST. ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN THE FORM OF INSERTING A DORSAL BRIDGING PLATE IN THE LEFT WRIST. ALSO INSERTED INSIDE PATIENT'S LEFT WRIST WERE NONLOCKING ANG LOCKING SCREWS. AFTER SURGERY, PATIENT WAS HOSPITALIZED UNTIL (B)(6) 2022, WHEN PATIENT WAS DISCHARGED TO HER HOME. PATIENT WAS IN PAIN AFTER SURGERY AND SOUGHT SEVERAL FOLLOW-UPS REGARDING THE PAIN SHE WAS EXPERIENCING IN RECOVERY. IN (B)(6) 2023, THE PAIN THAT THE PATIENT EXPERIENCED RESULTED IN AN ADDITIONAL VISIT TO THE OFFICE OF THE DOCTOR, WHO DISCOVERED ON (B)(6) 2023, THE DORSAL BRIDGE PLATE WAS BROKEN. AS A DIRECT OF THE FAILURE OF THE DORSAL BRIDGE PLATE, THE PLATE WAS REMOVED ON (B)(6) 2023 AND REPLACED WITH NEW HARDWARE.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.