HUNTER PASSIVE TENDON IMPLANT 4MM X 25CM

Description of Event or Problem

IT WAS REPORTED THAT THE STANDARD HUNTER TENDON ROD FAILED IN PATIENT. THE PHYSICIAN EXPLAINED THAT THE SUTURE TIED INTO IMPLANT BROKE/IMPLANTS CORE SEEMED HOLLOWED OUT. REPLACED WITH SAME ROD.

Additional Manufacturer Narrative

ONCE THE INVESTIGATION IS COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative

THE REPORTED EVENT COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE BECAUSE THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT IDENTIFY ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT IDENTIFY ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL-RELATED, MANUFACTURING-RELATED, OR DESIGN-RELATED ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. MORE DETAILED INFORMATION REGARDING THE COMPLAINT EVENT, INCLUDING PREOPERATIVE AND POSTOPERATIVE RADIOGRAPHS AS WELL AS THE AFFECTED DEVICE, IS REQUIRED IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

Description of Event or Problem

IT WAS REPORTED THAT THE STANDARD HUNTER TENDON ROD FAILED IN PATIENT. THE PHYSICIAN EXPLAINED THAT THE SUTURE TIED INTO IMPLANT BROKE/IMPLANTS CORE SEEMED HOLLOWED OUT. REPLACED WITH SAME ROD.