BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS LARGE

    MDR report key: 4405395 · Received January 9, 2015

    Report

    Report Number
    2530088-2015-10022
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Date of Event
    December 4, 2014
    Report Date
    December 15, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING EVALUATION: (B)(4) WAS CHECKED ON THE FORCEPS AND BROKEN PART AND IT WAS FOUND CORRECT. HARDNESS (45¿50 HRC) WAS FOUND ACCEPTABLE, READING 45 HRC. FEATURES FOUND OUT OF TOLERANCE ARE NOT CONSIDERED TO IMPACT OR GENERATE THE COMPLAINT CONDITION AS 0.5+0.3MM (0.5/0.8MM) READING 0.498MM CAN BE THE RESULT OF THE USAGE OF THE FORCEPS IN THE SERRATED SECTION, AND DIA 3+/-0.2MM (2.8/3.2MM) READING 2.758MM IS EXPECTED AS THIS READING WAS PERFORMED ON A TRANSITIONAL AREA FROM SECTION D-D TO SECTION C-C. NOTE: R0.2MM HAS A TOLERANCE OF +/- 0.2MM, THUS THE MINIMUM ALLOWABLE DIMENSIONS IS 0. AS A SHARP CORNER IS ALLOWED ON THE ROOT OF THE TEETH PER DESIGN, STRESSED AREA CAN POTENTIALLY BROKE AS EFFECT OF THE FORCE APPLIED ON THE INSTRUMENT MAGNIFIED BY 2.5 TIMES ON THE SERRATED TEETH. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS INDICATES THAT: THIS PART WAS MANUFACTURED AT (B)(4) WITH THE EXCEPTION OF ETCH, PASSIVATION AND FINAL INSPECTION, WHICH WERE PERFORMED BY (B)(4). THE PART NUMBER AND LOT NUMBER OF THE COMPLAINT MATCHES THE TOP LEVEL DHR PART NUMBER AND LOT NUMBER. REVIEW OF THE TOP LEVEL (B)(4) PORTION OF THE DHR SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE REVIEW OF THE (B)(4) INSPECTION RECORDS CONFIRM THAT THE COMPONENTS AND /OR FINAL PRODUCT, AS APPLICABLE, MET INSPECTION RECORDS, CERTIFICATION TEST VALUES, AND ACCEPTANCE CRITERIA. IT IS SUGGESTED THAT THIS COMPLAINT BE FORWARDED TO (B)(4) FOR FURTHER DHR REVIEW. (NO REVIEW OF THE RAW MATERIAL DHR WAS PERFORMED SINCE PRODUCT WAS MFR'D AT (B)(4)). THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT # DOES NOT CORRESPOND TO A (B)(4) DEVICE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE WAS RECEIVED HOWEVER THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL SYSTEM SURGERY ON (B)(6) 2014, THE TIP OF THE LARGE REDUCTION FORCEPS USED TO HOLD THE BONE TOGETHER BROKE OFF. THERE WAS A TIME DELAY OF FIVE TO TEN MINUTES WITH NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE FRAGMENT WAS RETRIEVED EASILY. THE PATIENT OUTCOME WAS REPORTED AS ¿FINE¿. THE SURGEON USED ANOTHER REDUCTION CLAMP FOR BACK-UP. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22781 REDUCTION FORCEPS LARGE FORCEPS HTD SYNTHES BRANDYWINE 5627766

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR