UNK - FIBULINK

Description of Event or Problem

THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR CLINICAL OUTCOMES OF 1,314 PATIENTS (74.2% MALE AND 52.4% FEMALE) WITH A MEAN AGE OF 44.2 (SD: 16.4) YEARS OLD UNDERGOING ANKLE JOINT SURGERY INVOLVING SYNDESMOTIC FIXATION WITH THE FIBULINK¿ SYNDESMOSIS REPAIR SYSTEM BETWEEN JANUARY 1, 2020, AND FEBRUARY 29. CLINICAL OUTCOMES WITHIN 12 AND 24 MONTHS AFTER INDEX PROCEDURE IN THE PHD: 49 PATIENTS HAD REVISION OF THE FIBULINK SYSTEM AT 12 MONTHS. 31 PATIENTS HAD INFECTION (DEEP OR SURGICAL SITE INFECTION) AT 12 MONTHS. 28 PATIENTS HAD ANKLE JOINT DERANGEMENT AT 12 MONTHS. 3 PATIENTS HAD POST-TRAUMATIC OR SECONDARY OSTEOARTHRITIS OF THE ANKLE AND FOOT AT 12 MONTHS. 55 PATIENTS HAD REOPERATION FOR ANKLE INJURIES FOR ANY REASON AT 12 MONTHS. 28 PATIENTS HAD REVISION OF THE FIBULINK SYSTEM AT 24 MONTHS. 16 PATIENTS HAD INFECTION (DEEP OR SURGICAL SITE INFECTION) AT 24 MONTHS. 25 PATIENTS HAD ANKLE JOINT DERANGEMENT AT 24 MONTHS. 7 PATIENTS HAD POST-TRAUMATIC OR SECONDARY OSTEOARTHRITIS OF THE ANKLE AND FOOT AT 24 MONTHS. 34 PATIENTS HAD REOPERATION FOR ANKLE INJURIES FOR ANY REASON AT 24 MONTHS. CLINICAL OUTCOMES WITHIN 12 AND 24 MONTHS AFTER INDEX PROCEDURE IN THE PHD: 10 PATIENTS HAD MECHANICAL COMPLICATION OF INTERNAL BONE FIXATION DEVICE OR OTHER INTERNAL ORTHOPEDIC DEVICES, IMPLANTS AND GRAFTS AT 12 MONTHS. 6 PATIENTS HAD MECHANICAL COMPLICATION OF INTERNAL BONE FIXATION DEVICE OR OTHER INTERNAL ORTHOPEDIC DEVICES, IMPLANTS AND GRAFTS AT 24 MONTHS.

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.

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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H.11. ADDITIONAL NARRATIVE: H6. COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. 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.