BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARP HOOK

    MDR report key: 6011523 · Received October 7, 2016

    Report

    Report Number
    2520274-2016-14828
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 19, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    GDG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (SHARP HOOK, PART NUMBER 319.39). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THAT AN APPROXIMATELY 8-10 MM PORTION OF THE TIP OF THE HOOK BROKE OFF INTRAOPERATIVELY. THERE WAS AN APPROXIMATELY 2 MINUTE SURGICAL DELAY AS THE BROKEN PORTION WAS RETRIEVED. THE COMPLAINT WAS ABLE TO BE CONFIRMED AT CUSTOMER QUALITY AS THE INSTRUMENT WAS RECEIVED WITH A PORTION OF THE HOOK TIP BROKEN OFF. THE BREAK IS LOCATED APPROXIMATELY 138 MM FROM THE PROXIMAL END OF THE DEVICE AND THE APPROXIMATELY 12 MM DISTAL TIP WAS RETURNED. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE SHARP HOOK (319.39) IS USED ACROSS VARIOUS PROCEDURES. THIS DEVICE IS INTENDED FOR SEVERAL APPLICATIONS SUCH AS REPOSITIONING FRAGMENTS, CHECKING ALIGNMENT OF FRACTURE ENDS, AND REMOVING INGROWN TISSUE FROM SCREW HEADS. PRODUCT DRAWING WAS REVIEWED DURING THE INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. REPLICATION OF THE COMPLAINT IS NOT APPLICABLE AS THE DEVICE WAS RECEIVED BROKEN. THE RECEIVED CONDITION IS INDICATIVE OF HAVING BEEN SUBJECTED TO FORCE BEYOND THE YIELD STRENGTH OF THE DEVICE. HOWEVER, THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AS THE METHOD OF USE AND MAINTENANCE AND THE CONDITIONS AT THE TIME OF THE DAMAGE ARE UNKNOWN. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHARP HOOK BROKE INTRA-OPERATIVELY. ON (B)(6), 2016 A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION TO REPAIR A RIGHT FRACTURED FIBULA. AS THE SURGEON BEGAN TO CLEAN THE FRACTURE WITH THE DEVICE, AN APPROXIMATE EIGHT TO TEN MILLIMETER PIECE OF THE HOOK BROKE OFF FROM THE CURVATURE OF THE HOOK AND FELL INTO THE FRACTURE AREA. THERE WAS A TWO MINUTE SURGICAL DELAY AS THE BROKEN PIECE WAS REMOVED INTACT FROM THE PATIENT. NO FRAGMENTS WERE REPORTED. A COMPARABLE DEVICE WAS USED TO CLEAN THE FRACTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661535 SHARP HOOK HOOK, SURGICAL, GEN & PLASTIC SURGERY GDG SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR