REMOVABLE EXTENSION ARM-FLEX 60MM FOR CMF DISTRACTOR

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. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY: 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.

Description of Event or Problem

PATIENT WAS TREATED FOR MANDIBULAR MICROGNATHIA DUE TO PREVIOUS ANKYLOSIS OF HER TEMPOROMANDIBULAR JOINTS. BILATERAL DISTRACTION DEVICES WERE INSERTED ON (B)(6) 2024. A TOTAL DISTRACTION OF APPROXIMATELY 25 MM WAS PERFORMED THROUGH THE FOLLOWING WEEKS (THE ACTIVE PERIOD PROLONGED DUE TO SOME LANGUAGE PROBLEMS). REMOVAL OF THE ACTIVATION ARMS WERE PLANNED (B)(6)2024 UNDER LOCAL ANAESTHESIA. THE ARM IN THE RIGHT SIDE WAS UNSCREWED AND REMOVED WITHOUT DIFFICULTY ACCORDING TO THE PROTOCOL. THE SAME PROCEDURE WAS FOLLOWED ON THE LEFT SIDE, BUT THE ARM COULD NOT BE RELEASED FROM THE DISTRACTION DEVICE. IT HAD TO BE CUT AS CLOSE TO THE SURFACE AS POSSIBLE, LEAVING THE REMAINDER OF THE ARM IN THE TISSUE. THE PATIENT HAD SOME DISCOMFORT DUE TO THIS, UNTIL THE DISTRACTION DEVICES WERE REMOVED ON (B)(6)2024]. ON THIS OCCASION, THE REMAINING PART OF THE ARM HAD SPONTANEOUSLY FALLEN OFF. THE FINAL RESULT WAS SATISFACTORY AND THE INCIDENT LED TO NO PERMANENT DAMAGES. SURGERY TIME WAS EXTENDED BY APPROXIMATELY TWENTY MINUTES.

Additional Manufacturer Narrative

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. 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.