BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    MDR report key: 3072417 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-10932
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    July 6, 2012
    Report Date
    July 6, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. ONE OF THE TIPS IS BROKEN OFF AT THE ROOT BETWEEN THE THIRD AND FOURTH TOOTH FROM THE HANDLE END AND THE BROKEN PIECE WAS RETURNED. THE FRACTURE SURFACES ARE SMOOTH AND THERE IS NO INDICATION OF MATERIAL ANOMALIES. THE FRACTURE FACE ON THE INSTRUMENT IS ANGLED ACROSS THE THICKNESS OF THE JAW WITH THE HIGHER SIDE ON THE INSIDE OF THE TIP. THE BROKEN PIECE HAS A LARGE DENT ON THAT SIDE APPROXIMATELY 5 MM FROM THE TIP. THE POINTS ON 5 OF THE TEETH ON THE BROKEN PIECE ARE FLATTENED AS ARE A COUPLE OF THE TEETH ON THE INTACT JAW. THE FORCEPS STILL ACTUATE AS DESIGNED AND THE LOCKING MECHANISM WORKS WELL. THERE IS A PIECE OF BLUE AND WHITE TAPE AROUND ONE OF THE HANDLES. THE DESIGN WAS REVIEWED AND DETERMINED TO BE ACCEPTABLE FOR THE INTENDED USE. THE COMPLAINT CONDITION IS THE RESULT OF AN IMPACT ON THE UNDERSIDE OF THE TIP AND THEREFORE THIS 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF OF A RADIAL FRACTURE, WHEN USING CLAMP IN SMALL FRAG, THE CLAMP BROKE INTO THE PATIENT. ALL PIECES WERE RETRIEVED. SURGEON COMPLETED PROCEDURE USING A DIFFERENT DEVICE WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173758 REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM HTD SYNTHES GMBH A7MA35 / 4651147

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR