BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE REDUCTION FORCEPS-LARGE

    MDR report key: 3053488 · Received April 11, 2013

    Report

    Report Number
    8030965-2013-10703
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    May 24, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

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

    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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION, VISUAL INSPECTION REPORTED THAT ONE OF THE TIPS IS BROKEN OFF AND THE MISSING PIECE WAS RETURNED. THE FRACTURE SURFACES ARE HOMOGENOUS AND THERE ARE NO INDICATIONS OF MATERIAL IRREGULARITIES. THE TIPS ARE WORN FROM USE AND THE TEETH HAVE SMALL DINGS ON THEM. THE FORCEPS OPEN AND CLOSE EASILY AND THE LOCKING MECHANISM HOLDS AND RELEASES AS INTENDED. THE PRODUCT DEVELOPMENT EVALUATION STATED THAT THIS DEVICE WAS MANUFACTURED IN JUNE 2003 AND HAS BEEN IN USE FOR OVER 9 YEARS WITHOUT ISSUE. THERE ARE (B)(4) OTHER COMPLAINTS IN THE 2 YEAR HISTORY FOR THIS CONDITION ON THIS PART AND APPROXIMATELY (B)(4) DISTRIBUTED OVER THAT TIME FOR A RATE BASED ON SALES OF APPROXIMATELY (B)(4). THIS INSTRUMENT IS USED REPEATEDLY SO THE RATE BASED ON USE WOULD BE MUCH LOWER AND THE COMPLAINT CONDITION PRESENTS MINIMAL RISK. THE (B)(4). THERE ARE NO INDICATIONS OF EITHER MANUFACTURING OR DESIGN RELATED ISSUES WITH THE DEVICE AND THE FRACTURE SURFACE IS UNIFORM AND CONSISTENT WITH AN OVER STRESS SITUATION WHICH WOULD BE IN EXCESS OF THAT TYPICALLY REQUIRED FOR THE INTENDED USE. 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 USE HISTORY SUPPORT THE CONCLUSION THAT THE DESIGN IS ACCEPTABLE AND THERE ARE NO DESIGN OR MANUFACTURING RELATED ISSUES. THE DESIGN IS ADEQUATE FOR THE INTENDED USE AND THE COMPLAINT CONDITION WAS CAUSED BY APPLICATION OF AN LOAD IN EXCESS OF THAT TYPICALLY SEEN FOR THIS TYPE OF INSTRUMENT. THEREFORE THE COMPLAINT IS INVALID.

    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 PARASYMPHYSEAL PLATING PROCEDURE (CHIN) THE SURGEON WAS USING FORCEPS TO REDUCE THE FRACTURE AND THE TIP OF THE FORCEPS BROKE OFF. THE BROKEN FRAGMENT WAS RETRIEVED IMMEDIATELY. THE SURGEON HAD ANOTHER FORCEP, SMALLER IN SIZE, IN THE SET THAT HE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154718 BONE REDUCTION FORCEPS-LARGE HTD SYNTHES GMBH A7MA20

    Patients

    Seq Age Sex Outcome Treatment
    1