PERFORM HUMERAL HEAD IMPACTOR TIP

Additional Manufacturer Narrative

ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

AS REPORTED: "THE INSTRUMENT BROKE WHILE IMPACTING THE GLENOID."

Additional Manufacturer Narrative

PLEASE NOTE CORRECTION TO D9. THE REPORTED EVENT COULD BE CONFIRMED, BASED ON THE PROVIDED IMAGES. THE VISUAL INSPECTION OF THE PROVIDED IMAGES REVEALS THE IMPACTOR TIP IS BROKEN INTO TWO PIECES. THE BREAKAGE PATTERN INDICATES IT TO BE A BRITTLE FRACTURE. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED, AND THE LOT NUMBER WAS NOT COMMUNICATED. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A WEAR & DESIGN RELATED ISSUE. THE FAILURE WAS CAUSED BY ITS INTENDED USE. AS A DEVICE THAT IS MANUFACTURED OF PLASTIC AND INCURS NUMEROUS IMPACTION EVENTS, CLEANING AND STERILIZATION CYCLES, BREAKAGE AS NOTED IN THIS COMPLAINT CAN BE EXPECTED. A DESIGN IMPROVEMENT IS IN PROGRESS TO PREVENT THE RECURRENCE OF THE ALLEGED FAILURE. IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

Description of Event or Problem

AS REPORTED: "THE INSTRUMENT BROKE WHILE IMPACTING THE GLENOID."

Additional Manufacturer Narrative

PLEASE NOTE CORRECTION TO D4 (LOT/SERIAL NO.) AND D9 (PRODUCT AVAILABLE TO STRYKER). THE REPORTED EVENT COULD BE CONFIRMED SINCE THE PRODUCT WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE RECEIVED DEVICE SHOWS SIGNS OF EXTENSIVE USAGE AS EVIDENT BY WEAR MARKS BLACK SPOTS & DEFORMED EDGES. THE IMPACTOR TIP IS BROKEN INTO TWO PIECES. THE BREAKAGE PATTERN INDICATES IT TO BE A BRITTLE FRACTURE DUE TO AN APPLICATION OF EXCESSIVE MECHANICAL FORCE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. BASED ON INVESTIGATION THE ROOT CAUSE WAS ATTRIBUTED TO A WEAR & DESIGN RELATED ISSUE. THE FAILURE WAS CAUSED BY ITS INTENDED USE. AS A DEVICE THAT IS MANUFACTURED OF PLASTIC AND INCURS NUMEROUS IMPACTION EVENTS CLEANING AND STERILIZATION CYCLES, BREAKAGE AS NOTED IN THIS COMPLAINT CAN BE EXPECTED. A DESIGN IMPROVEMENT IS IN PROGRESS TO PREVENT THE RECURRENCE OF THE ALLEGED FAILURE. IF ANY FURTHER INFORMATION IS PROVIDED THE COMPLAINT REPORT WILL BE UPDATED.

Description of Event or Problem

AS REPORTED: "THE INSTRUMENT BROKE WHILE IMPACTING THE GLENOID."