BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREWDRIVER

    MDR report key: 6338142 · Received February 16, 2017

    Report

    Report Number
    1719045-2017-10117
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Report Date
    January 23, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    UDI-DI
    07611819790735
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (EXTRACTION SCREWDRIVER, PART NUMBER 352.311, LOT NUMBER 6434506). THE 388.349 / LOT NO 563961E06: THE RECEIVED INSTRUMENT SHOWS SCRATCHES AND MARKS ALLOVER ON THE SURFACE. MOREOVER WE FOUND THAT TWO OF FOUR POSITIONING GUIDES, WHICH ARE LOCATED IN FRONT OF THE TIP, ARE BROKEN. THE BROKEN PARTS ARE MISSING. WE DO SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING USE COULD LEAD TO THE BREAKAGE. THE 352.311 / LOT NO 560369E06: THE RECEIVED INSTRUMENT SHOWS SCRATCHES AND MARKS ALLOVER ON THE SURFACE. MOREOVER WE FOUND THAT INNER SHAFT THREAD AND THE HEXAGONAL TORX TIP ARE BROKEN. THE BROKEN FRAGMENTS ARE MISSING. WE DO SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING USE COULD LEAD TO THE BREAKAGE. THE 352.311 / LOT NO 6434506: THE RECEIVED INSTRUMENT SHOWS SCRATCHES AND MARKS ALLOVER ON THE SURFACE. MOREOVER WE FOUND THAT INNER SHAFT THREAD IS BROKEN. THE BROKEN FRAGMENTS PARTS ARE MISSING. WE DO SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING USE COULD LEAD TO THE BREAKAGE. THE 03.636.003 / LOT NO 3563509; 03.636.003 / LOT NO 3224831; 03.636.003 / LOT NO 3782034; 03.636.003 / LOT NO 3253558; 03.636.003 / LOT NO 3106657; 03.636.003 / LOT NO 3694217: THE RECEIVED INSTRUMENTS HAVE SCRATCHES AND MARKS ALLOVER ON THE SURFACE. MOREOVER SEVERAL DEVICES WERE FOUND BROKEN AT POSITIONING CAMS AND PINS. THE BROKEN PARTS ARE MISSING. WE DO SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING USE COULD LEAD TO THE MULTIPLE BREAKAGES. OUR INVESTIGATION HAS SHOWN, THAT WE RECEIVED TEN PARTS FROM SERVICE AND REPAIR DEPARTMENT WHICH ARE NOT REPAIRABLE ANYMORE. HOWEVER, BECAUSE OF THE SEVERAL DAMAGES THIS COMPLAINT IS RATED AS CONFIRMED. THE MANUFACTURING REVIEW, OF ALL RECEIVED PARTS, DOES SHOW THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. UNFORTUNATELY, WE ONLY HAVE LIMITED INFORMATION IN THE COMPLAINT DESCRIPTION AND CANNOT CONFIRM HOW THE BREAKAGES HAPPENED. THERE ARE WEAR AND TEAR SIGNS ON EACH INSTRUMENT VISIBLE, WHICH ARE MOST LIKELY REFERABLE DO AN OFTEN AND INTENSIVE USE OVER THE YEARS, AS MOST DEVICES ARE OLDER THAN 10 YEARS. FURTHERMORE, WE DO SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING USE COULD LEAD TO THE BREAKAGES. AT THIS POINT WE WANT TO BRING UP OUR RECOMMENDATIONS IN OUR LEAFLET, WHICH DESCRIBES THE END OF LIFE OF AN INSTRUMENTS AT PAGE 4: "END OF LIFE OF A DEVICE IS NORMALLY DETERMINED BY WEAR AND DAMAGE DUE TO USE. EVIDENCE OF DAMAGE AND WEAR ON A DEVICE MAY INCLUDE BUT IS NOT LIMITED TO CORROSION (I.E. RUST, PITTING), DISCOLORATION, EXCESSIVE SCRATCHES, FLAKING, WEAR AND CRACKS. IMPROPERLY FUNCTIONING DEVICES, DEVICES WITH UNRECOGNIZABLE MARKINGS, MISSING OR REMOVED (BUFFED OFF) PART NUMBERS, DAMAGED AND EXCESSIVELY WORN DEVICES SHOULD NOT BE USED." BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED. FINALLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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. THERE WAS NO REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE/RELEASE TO WAREHOUSE DATE: (B)(6) 2010. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TEN (10) BROKEN DEVICES WERE RECEIVED BY SERVICE AND REPAIR WITH NO INFORMATION REGARDING HOW OR WHEN THE DEVICES WERE BROKEN. THERE WAS NO REPORT OF PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 3 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119050 EXTRACTION SCREWDRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 6434506 07611819790735

    Patients

    Seq Age Sex Outcome Treatment
    1