FIBULINK SYNDESMOSIS REPAIR KIT TI

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE SCREW COULD NOT BE REMOVED IN THE REMOVAL SURGERY ON (B)(6) 2025. THIS PC REPORTS AN INFECTION THAT WAS CONFIRMED AFTER PRIMARY SURGERY AND REMOVAL SURGERY WAS PERFORMED. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT PRIMARY SURGERY FOR OPEN ANKLE FRACTURE-DISLOCATION WITH FIBULINK REPAIR KIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2025, THE SALES REP WAS INFORMED BY THE SURGEON THAT THE FIBULINK REPAIR KIT WAS SCHEDULED TO BE REMOVED DUE TO SIGNS OF INFECTION IN THE WOUND. ON (B)(6) 2025, THE SURGERY WAS PERFORMED TO REMOVE THE FIBULINK REPAIR KIT ALONG WITH A DISTAL FIBULA PLATE FROM ANOTHER MANUFACTURER. NO FURTHER INFORMATION IS AVAILABLE. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE X-RAY INVESTIGATION REVEALED NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE. IT CAN BE OBSERVED THE SCREW IMPLANTS WITH NO DEFECT. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE FIBULINK SYNDESMOSIS REPAIR KIT TI WOULD HAVE NOT CONTRIBUTED TO THE REPORTED ADVERSE EVENT. 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 REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPEDICS 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. DEVICE HISTORY LO PART # FGS-1100 SYNTHES LOT # 23E016 SUPPLIER LOT # 23E016 RELEASE TO WAREHOUSE DATE: 01 NOV 2023 SUPPLIER: (B)(4) NO NCR'S GENERATED DURING PRODUCTION. DEVICE HISTORY BATCH NULL DEVICE HISTORY REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

Description of Event or Problem

THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE SCREW COULD NOT BE REMOVED IN THE REMOVAL SURGERY ON (B)(6) 2025. THIS PC REPORTS AN INFECTION THAT WAS CONFIRMED AFTER PRIMARY SURGERY AND REMOVAL SURGERY WAS PERFORMED. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT PRIMARY SURGERY FOR OPEN ANKLE FRACTURE-DISLOCATION WITH FIBULINK REPAIR KIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2025, THE SALES REP WAS INFORMED BY THE SURGEON THAT THE FIBULINK REPAIR KIT WAS SCHEDULED TO BE REMOVED DUE TO SIGNS OF INFECTION IN THE WOUND. ON (B)(6) 2025, THE SURGERY WAS PERFORMED TO REMOVE THE FIBULINK REPAIR KIT ALONG WITH A DISTAL FIBULA PLATE FROM ANOTHER MANUFACTURER. NO FURTHER INFORMATION IS AVAILABLE.