BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARP HOOK

    MDR report key: 3013931 · Received March 20, 2013

    Report

    Report Number
    8030965-2013-10574
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GDG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE HISTORY RECORD WAS NOT ARCHIVED, INSTRUMENT IS NEARLY 7 YEARS OLD. THE MANUFACTURING EVALUATION SHOWED THAT THE TIP WAS EXTREMELY DEFORMED. THE SHARP HOOK CORRESPONDS TO THE DRAWING AND PROCESSES AT THE TIME OF MANUFACTURE. TOO MUCH FORCE WAS APPLIED TO THE TIP CAUSING IT TO BEND. IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(4) 2012.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANKLE FRACTURE PROCEDURE, THE TIP OF THE SHARP HOOK (319.39) BROKE WHILE THE SURGEON WAS REDUCING THE FRACTURE. THE BROKEN FRAGMENT WAS RETRIEVED. DURING THE PROCEDURE, THE UNIVERSAL CHUCK WITH T-HANDLE BECAME STUCK. THE SCHANZ PIN IN THE UNIVERSAL CHUCK WITH T-HANDLE AND IT WOULD NOT COME APART. SURGEON USED ANOTHER SHARP HOOK AND UNIVERSAL CHUCK WITH T-HANDLE TO COMPLETE THE PROCEDURE WITH NO HARM TO PATIENT. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116136 SHARP HOOK GDG SYNTHES GMBH A7OA34

    Patients

    Seq Age Sex Outcome Treatment
    1