BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE/FIXED HAMMER 700 GRAMS

    MDR report key: 3020355 · Received March 25, 2013

    Report

    Report Number
    8030965-2013-10608
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    March 5, 2012
    Report Date
    March 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. MANUFACTURING EVALUATION REPORTS THE SAMPLE WAS RECEIVED WITHOUT VISIBLE BREAKAGE AT THE NUT. A TREMENDOUS NICK IS LOCATED ALONG THE THREAD AT THE FOREFRONT. THE INVESTIGATION HAS SHOWN THAT THE NUT CANNOT BE SCREWED ON THE THREAD NEXT TO THE HAMMER HEAD. THIS IS CAUSED BY AN EXTREME NICK ALONG THE THREAD. THIS NICK IN COMBINATION WITH HEAVY HAMMER MARKS AT THE EDGE OF THE HAMMER HEAD ABOVE THE DAMAGED THREAD IS INDICATIVE OF THE TARGET HAMMER SPOT BEING MISSED DURING HAMMERING. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PRODUCT DEVELOPMENT EVALUATION REVEALS THE NUT IS INTACT WITHOUT SIGNS OF MISSING OR BROKEN FRAGMENTS. THREADS NEAR THE HEAD SHOW DAMAGE INDICATIVE OF HARD BLOW AGAINST SHARP OBJECT. THREAD DAMAGE PREVENTS NUT FROM ENGAGING. DEVICE IS DAMAGED BUT NOT AS DESCRIBED. DESIGN RELATED ISSUES WERE NOT FOUND. THIS COMPLAINT IS CONSIDERED INVALID FROM A MANUFACTURING PERSPECTIVE.

    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)(6) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FEMUR AND ELBOW FRACTURE PROCEDURE, SURGEON USED THE SLIDE/FIXED HAMMER AND THE CONNECTING NUT THAT ADHERES THE WEIGHT OF THE HAMMER BROKE. THE BROKEN FRAGMENT WAS RETRIEVED. SURGEON WAS ABLE TO USE ANOTHER HAMMER TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THE PATIENT WAS UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122814 SLIDE/FIXED HAMMER 700 GRAMS LXH SYNTHES GMBH 1548168

    Patients

    Seq Age Sex Outcome Treatment
    1