BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE REDUCTION FORCEPS-LARGE

    MDR report key: 2972554 · Received February 21, 2013

    Report

    Report Number
    8030965-2013-10224
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. 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. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE COMPLETED DUE TO THE AGE OF THE DEVICE. AS RECEIVED, ONE OF THE TIPS OF THE DEVICE WAS BROKEN OFF AND THE MISSING PIECE WAS NOT RETURNED. THE FRACTURE SURFACE WAS HOMOGENOUS, WHICH INDICATES MATERIAL UNIFORMITY; THERE WERE NO INDICATIONS OF MATERIAL IRREGULARITIES. THE REMAINING TIP WAS WORN FROM USE AND THE TEETH HAD SMALL DINGS ON THEM. THE FORCEPS OPENED AND CLOSED EASILY, AND THE LOCKING MECHANISM HELD AND RELEASED AS DESIGNED. BASED ON THE CONDITION OF THE DEVICE, IT HAS SEEN EXTENSIVE USE. THERE ARE NO INDICATIONS OF EITHER MANUFACTURING OR DESIGN RELATED ISSUES. THE FRACTURE SURFACE WAS UNIFORM AND CONSISTENT WITH AN OVER-STRESS SITUATION. THE SPECIFIC CONDITIONS OF THE CASE IN WHICH THIS INSTRUMENT BROKE ARE NOT KNOWN, BUT THE FAILURE IS CONSISTENT WITH THE DEVICE BEING SUBJECTED TO EXTREMELY HIGH LOAD WHICH CAUSED THE TIP TO BREAK. THAT, COUPLED WITH THE AGE AND APPARENT USE HISTORY, SUPPORT THE CONCLUSION THAT THE DESIGN IS ACCEPTABLE AND THERE ARE NO MANUFACTURING RELATED ISSUES.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MANDIBLE FRACTURE CASE, THE SURGEON WAS REDUCING THE MANDIBLE AND THE TIP OF THE INSTRUMENT BROKE OFF INTO THE WOUND. THE SURGEON RETRIEVED THE FRAGMENT AND COMPLETED THE PROCEDURE WITH ANOTHER FORCEPS WITH NO FURTHER PROBLEM.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76560 BONE REDUCTION FORCEPS-LARGE HTD SYNTHES GMBH A7 HA 20

    Patients

    Seq Age Sex Outcome Treatment
    1