BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM

    MDR report key: 3082687 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11011
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 14, 2011
    Report Date
    November 14, 2011
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. HOWEVER, THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING LOCATION UPDATED TO (B)(4).

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF, OPEN REDUCTION INTERNAL FIXATION OF THE PATIENTS ULNA, ONE OF THE PRONGS ON THE REDUCTION FORCEPS SNAPPED OFF DURING THE PROCEDURE. THE BROKEN PIECE WENT INTO THE CLAMP BUT DID NOT FALL INTO THE PATIENTS CAVITY. THE RATCHET ON THE SECOND FORCEPS DID NOT WORK AND NOTHING BROKE OFF INTO THE PATIENT. SURGEON USED ANOTHER CLAMP FROM ANOTHER SET AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183906 REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM HTD SYNTHES TUTTLINGEN T922356

    Patients

    Seq Age Sex Outcome Treatment
    1