BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOHMANN STYLE ARM 183MM

    MDR report key: 3003436 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10427
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    June 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 FEB 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MFG INVESTIGATION REVEALED THE ARM IS SIZED ON THE CLAMP. THE VISUAL SPECIFICATION INVESTIGATION SHOWED THAT THE ARM IS COMPLETELY SIZED ON THE CLAMP AND THAT THE RELEASE MECHANISM OF THE ARM IS STUCK. THIS MAKES DISASSEMBLING OF THE PARTS IMPOSSIBLE AND THEREFORE WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THE OCCURRENCE. WE FOUND THAT THE ARM IS NOT PARALLEL ON THE CLAMP AND THAT THERE ARE SOME HEAVY DENTS AT THE ARM. THIS LETS US SUPPOSE THAT EXTREME FORCES WERE APPLIED ONTO THIS INSTRUMENT, WHICH COULD HAVE CAUSED THE SEIZING. IT IS CONCLUDED THAT THIS COMPLAINT IS INDETERMINATE FROM A MFG STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANKLE FRACTURE PROCEDURE, A CLAMP BROKE. THE SURGEON HAD ATTACHED THE CLAMP (HOHMANN STYLE ARM 398.752) TO THE TRIGGER (SLIDING MECHANISM 314.291) TO REDUCE THE FRACTURE. HE THEN WANTED TO CHANGE TO ANOTHER ATTACHMENT, BUT THE CLAMP BROKE AND IS JAMMED/STUCK ON THE TRIGGER, AND CANNOT BE DISLODGED. THE SURGEON CHANGED TO A LEVER CLAMP TO COMPLETE THE PROCEDURE. THE SURGERY WAS EXTENDED BY 5-10 MINUTES. NOTHING BROKE INTO THE WOUND, AND THERE WERE NO PIECES TO RETRIEVE. THIS REPORT IS ON THE HOHMANN STYLE ARM. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87163 HOHMANN STYLE ARM 183MM HTD SYNTHES GMBH 09-2206

    Patients

    Seq Age Sex Outcome Treatment
    1