BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR TREPHINE ATTACHMENTS

    MDR report key: 3305333 · Received August 23, 2013

    Report

    Report Number
    8030965-2013-04638
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Date of Event
    July 25, 2013
    Report Date
    July 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION SHOWED TWO OF THE THREE PRONGS ARE BROKEN OFF AND WERE NOT SEND BACK FOR INVESTIGATION. THERE ARE CLEARLY VISIBLE STRESS MARKS AT THE HEXAGON ABOVE THE PRONGS. NOT ALL RELEVANT DIMENSIONS CAN NOT BE VERIFIED ANYMORE BECAUSE OF THE DAMAGE AND AS THE BROKEN FRAGMENTS WERE NOT SENT BACK FOR INVESTIGATION. AS DOCUMENTED IN THE MANUFACTURING DOCUMENTS THE CORRECT MATERIAL WAS USED ((B)(4)) AND THE HARDNESS WAS WITH 55 HRC WITHIN THE SPECIFICATION OF 53-56 HRC. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY AND HAS THE TYPICAL VIEW OF A FORCED FRACTURE. BASED ON THAT AND THE CLEARLY VISIBLE STRESS MARKS AT THE HEXAGON WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD DURING USE CAUSED THIS BREAKAGE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION SHOWED THE RETURNED SHAFT FOR TREPHINE ATTACHMENTS (PART 03.111.030) WAS RETURNED FOR EVALUATION WITH COMPLAINT CATEGORY OF BROKE. THE RETURNED DEVICE (LOT 2802733) WAS MANUFACTURED NOVEMBER 2011. ON THE RETURNED DEVICE, TWO OF THE THREE DISTAL TINES HAVE SHEARED OFF AT THEIR BASE. THE TINE FRAGMENTS WERE NOT RETURNED FOR EVALUATION. THE BREAK IS CLEAN AND STRAIGHT ACROSS ON ONE TINE, AND ONE JAGGED CORNER EXISTS ON THE OTHER BROKEN TINE. THE BREAKS OCCUR AT THE JUNCTION BETWEEN THE STRAIGHT SECTION OF THE TINE AND THE RADIUSED TRANSITION ZONE TO THE CONNECTING HEX FEATURE. THE SHAFT FOR TREPHINE ATTACHMENTS IS DESIGNED TO COUPLE WITH TREPHINE ATTACHMENTS AND EXTRACTION ATTACHMENTS. REVIEW OF PRODUCT DRAWING SE 193870, REV. E, SHOWS THAT THE SHAFT IS MANUFACTURED FROM 440B STAINLESS STEEL, WHICH IS AN APPROPRIATE MATERIAL USED FOR SURGICAL APPLICATIONS PER ASTM F899. THE CANNULATION IS NECESSARY TO PROVIDE PRECISE PLACEMENT VIA GUIDEWIRE. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT. THE ORTHOPEDIC FOOT INSTRUMENTS DESIGN AND CLINICAL RISK MANAGEMENT (SE 201596, REV. AF) DOES ADDRESS THE RISK OF THE COUPLING TINES BREAKING. SPECIFICALLY, LINE 185 LISTS THE HAZARD OF THE SYSTEM NOT BEING ABLE TO BE USED AS INTENDED DUE TO BENDING OR BREAKING OF COUPLING TINES (SNAP MECHANISM) AS ACCEPTABLE RISK WITH MARGINAL SEVERITY OF HARM 2 AND AN UNLIKELY PROBABILITY OF OCCURRENCE 2 WITH POSSIBLE HARM LISTED AS NO HARM TO PATIENT, INSTRUMENT CAN NOT BE USED, SHORT PROLONGING OF SURGERY. THERE ARE (B)(4) COMPLAINTS FOR PART 03.111.030 WITH COMPLAINT CATEGORY OF BROKE IN THE ENTIRE COMPLAINT HISTORY (SEARCH PERIOD FROM 8/19/1990 THROUGH 8/19/2013 IN WHICH THE DISTAL TINES BROKE. THERE HAVE BEEN (B)(4) MATING PARTS SOLD (03.111.025-03.111.028 INCLUSIVE, 03.111.030, 03.111.031, 387.659-387.663 INCLUSIVE, AND 387.669-387.673 INCLUSIVE). A CONSERVATIVE APPROACH TO ESTIMATE USAGE WOULD BE TO INFER THAT EACH ATTACHMENT DISTRIBUTED HAS BEEN USED AT LEAST TWICE. THEREFORE, AN ESTIMATED OCCURRENCE RATE BASED ON USAGE WOULD BE ((3,047 SOLD X 2 USES)/8 COMPLAINTS) YIELDING AN ESTIMATED OCCURRENCE RATE OF 0.1% WHICH IS WITHIN THE RANGE OF THE ESTIMATED RATE FROM THE RISK ANALYSIS. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT. THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE UNDERWENT A SUBTALAR ARTHRODESIS ON (B)(6) 2013. WHILE THE SURGEON WAS HARVESTING BONE FROM THE TIBIA, TWO OF THE THREE PINS FROM THE DISTAL END OF THE SHAFT FOR THE TREPHINE ATTACHMENT BROKE OFF. BOTH PINS WERE RECOVERED AND DISCARDED; NO FRAGMENTS WERE REPORTED. IT WAS REPORTED THAT THE BROKEN PINS WERE REMOVED EASILY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY OR NEED FOR ANOTHER DEVICE. IT WAS REPORTED THAT THE PATIENT WAS WELL AFTER THE PROCEDURE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415055 SHAFT FOR TREPHINE ATTACHMENTS HWK SYNTHES GMBH 2802733

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR