SUTURE HOOK CRESCENT MED LIMITED REUSE

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: THE DEVICE WAS RECEIVED FOR EVALUATION WITHOUT THE DETACHED PORTION. DURING A VISUAL EXAMINATION, THE NEEDLE WAS FOUND DETACHED AT THE WELD. FURTHER INSPECTION NOTED THAT THE OUTER TUBE WAS BENT. THE INFORMATION FOR USE (IFU) INFORMS THE USER OF THE FOLLOWING: CAUTIONS: AVOID LATERAL STRESSES TO THE INSTRUMENTS OR DEVICE FUNCTION MAY BE COMPROMISED AND UNINTENTIONAL PATIENT INJURY MAY RESULT. DO NOT USE IF PARTS ARE BROKEN, CRACKED OR WORN, OR DEVICE FUNCTION MAY BE COMPROMISED. AVOID MECHANICAL SHOCK OVER STRESSING THE INSTRUMENT WHICH MAY SHORTEN THE LIFE OF THE INSTRUMENT. INSTRUMENTS (HANDLE AND LIMITED REUSE HOOKS) SHOULD BE STORED IN THE SPECTRUM II STERILIZATION TRAY TO PROTECT THE FAILURES. AN INVESTIGATION REMAINS IN PROCESS FOR THIS FAILURE MODE. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR FAILURES.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, THE SUTURE HOOK TIP BROKE OFF AND WAS RETRIEVED USING GRASPING FORCEPS. THERE WAS NO INJURY OR SURGICAL DELAY RELATED TO THIS EVENT.