BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARP HOOK

    MDR report key: 3020926 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-10602
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 12, 2012
    Report Date
    March 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. ORIGINAL AWARENESS DATE IS 3/12/12. PLACEHOLDER.

    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. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TALUS FRACTURE PROCEDURE THE SURGEON COMPLAINED TO THE SALES CONSULTANT THAT THE TIPS OF THE SHARP HOOKS BROKE OFF DURING USE IN THE PATIENT. ONE TIP WAS RETRIEVED. THE SECOND TIP COULD NOT BE FOUND. X-RAY WAS TAKEN DURING THE PROCEDURE CONFIRMING THE TIP WAS NOT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123453 SHARP HOOK LXH SYNTHES GMBH T959236

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR