CABLE-READY CABLE GRIP SYSTEM CERCLAGE CABLE WITH NEEDLE AND CRIMPS

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3; B4; B5; B6; D2; D6; D9; G1; G3; G4; G6; H1; H2; H3; H6. CORRECTIONS TO B3 AND D6. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PIN-AND-CABLE FIXATION OF A DISPLACED TRANSVERSE OLECRANON FRACTURE. THERE IS LOSS OF FRACTURE FIXATION WITH MIGRATION OF ONE OF THE PINS AND FRACTURE OF THE CABLE. THE WIRE, NEEDLE, AND LEADER WERE NOT RETURNED. IT IS UNKNOWN WHETHER OR NOT ALL OF THE CABLE HAS BEEN RETURNED. SEM ANALYSIS IDENTIFIED THAT MOST WIRES SHOWED SIGNIFICANT SMEARING AND POSSIBLE BIOLOGICAL DEBRIS. ON TWO WIRES, FRACTURE SURFACE ARTIFACTS OF DUCTILE DIMPLES WERE OBSERVED IN UNSMEARED REGIONS. FRACTURE SURFACE ARTIFACTS OF DUCTILE DIMPLES ARE CONSISTENT WITH THE OVERLOAD FAILURE MODE; HOWEVER, THE INITIATION FAILURE MODE CANNOT BE DETERMINED WITH CERTAINTY DUE TO THE EXCESSIVE SMEARING ON ALL OBSERVED WIRES. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR A PATELLAR FRACTURE WITH A CABLE SYSTEM. APPROXIMATELY 10 DAYS POST-IMPLANTATION, THE PATIENT EXPERIENCED PAIN AND RADIOGRAPHIC EVALUATION SHOWED THE CABLE WAS BROKEN. APPROXIMATELY 1 DAY LATER, THE PATIENT UNDERWENT REVISION SURGERY. THE PATIENT UNDERWENT REVISION; NO ADDITIONAL POSTOPERATIVE DETAILS WERE PROVIDED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

(B)(4). E1: (B)(6). E1: PHONE NUMBER - (B)(6). G2: FOREIGN - EVENT OCCURRED IN CHINA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.