SUTURE HOOK TIP, STRAIGHT LIMITED REUSE

Additional Manufacturer Narrative

NO MEDWATCH FORM RECEIVED FROM THE USER FACILITY. ALL SECTIONS ON THIS FORM COMPLETED BY THE MANUFACTURER. INVESTIGATION FINDINGS: AN EVALUATION OF THIS DEVICE COULD NOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE FACILITY, AND WILL NOT BE RETURNED TO CONMED LINVATEC. THIS IS LABELED AS A LIMITED REUSE ITEM. IN ADDITION, THE INFORMATION FOR USE (IFU) INFORMS THE USER TO INSPECT INSTRUMENTS BEFORE AND AFTER PROCESSING FOR PROPER FUNCTION AND ALIGNMENT OF PINS AND FOR CHIPPING OF PLATED SURFACES. A REVIEW OF PRODUCT HISTORY FOR THE PAST 2 YEARS NOTED TWO OTHER SIMILAR REPORTED PROBLEMS. AN EXAMINATION OF OTHER RETURNED DEVICES FOUND THE TIP DETACHED AT THE WELD AND THE OUTER TUBE SEVERELY BENT RELATED TO EXCESSIVE OR LATERAL FORCE. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR FAILURES.

Description of Event or Problem

IT WAS REPORTED THAT THE TIP OF THIS SUTURE HOOK BROKE DURING USE IN AN ARTHROSCOPIC ANTERIOR STABILIZATION PROCEDURE OF THE RIGHT SHOULDER. THE TIP WAS RETRIEVED WITH FORCEPS. AN ALTERNATE HOOK WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT INJURY OR SURGICAL DELAY.