BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVREDUCFORCEPS SM F/SCR Ø3.5 L250

    MDR report key: 3193639 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-02954
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    September 27, 2011
    Report Date
    October 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. (B)(6). A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE INVESTIGATION OF THE COMPLAINED INSTRUMENT SHOWS THAT THE SCREW IS INDEED BROKEN OFF. IT IS CLEARLY VISIBLE THAT THE BROKEN SCREW, AS WELL AS THE SURFACE OF THE FORCEPS-NEAR THE HOLE-ARE RUSTY. THIS LEAD US TO BELIEVE THAT THE BREAKAGE MAY HAVE BEEN CAUSED BY CORROSION. CONCERNING THE VISIBLE SIGNS OF CORROSION, IT HAS TO BE POINTED OUT THAT EVEN SO-CALLED STAINLESS STEEL IS ONLY RUST RESISTANT. THE CORROSION RESISTANCE IS ONLY ENSURED WHEN THE PRODUCTS ARE STORED AT DRY CONDITIONS. IN ADDITION, ALL METALLIC CONTACTS AT HUMID OR WET CONDITIONS MAY CREATE ELECTROLYTIC REACTIONS, RESULTING IN CONTACT CORROSION. WE DETERMINE, AS THIS IS AN OLD AND OFTEN USED INSTRUMENT, AND WE HAVE NOT HAD A SINGLE COMPLAINT SO FAR, AS AN ISOLATED CASE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    THE PELVIC REDUCTION FORCEPS BROKE. WHILE IN USE THE FORCEPS BROKE WITH THE INNER SCREW SHEARING OFF. THIS IS 1 OF 1 REPORT FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293217 PELVREDUCFORCEPS SM F/SCR Ø3.5 L250 HTD SYNTHES GMBH A7PA26

    Patients

    Seq Age Sex Outcome Treatment
    1