BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE INSERT F/EXTRACT 2+2.4 T6+T8 F/DR

    MDR report key: 6241498 · Received January 11, 2017

    Report

    Report Number
    3003875359-2017-10017
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Report Date
    December 28, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IT IS UNKNOWN WHEN EVENT OCCURRED. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN COMPLETED:MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: NOVEMBER 6, 2003, EXPIRY DATE: MARCH 1, 2014. NO NON-CONFORMANCE RECORDS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE DOUBLE INSERT FOR EXTRACTION INSTRUMENT(PART NUMBER 309.551S, LOT NUMBER 1192855). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING A PIECE OF THE SCREWDRIVER IS BROKEN OFF, THE FRAGMENT WAS NOT SENT BACK FOR EVALUATION. DUE TO THE DAMAGE THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE. THE COMPLAINT IS CONFIRMED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THIS DEVICE WAS MANUFACTURED IN NOVEMBER 2003 ACCORDING TO THE SPECIFICATION. THE REVIEW HAS SHOWN THAT WITH 1.4028 THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS BETWEEN 532 HV WHICH IS WITHIN THE SPECIFICATION OF 485 +60/0 HV10 OF DRAWING. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. THE MOST PROBABLE ROOT CAUSE IS A MECHANICAL OVERLOAD DURING THE EXTRACTION PROCEDURE. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIPS OF TWO STARDRIVE SCREWDRIVERS AND AN DOUBLE INSERT FOR EXTRACTION BECAME DEFORMED INTRAOPERATIVELY ON AN UNKNOWN DATE DURING PLANNED IMPLANT REMOVAL OF A CLAVICULA PLATE CONSTRUCT. NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. PATIENT STATUS IS UNKNOWN. ON (B)(6) 2016, IT WAS DETERMINED DURING THE INVESTIGATION THAT ONE STARDRIVE TIP AND THE DOUBLE INSERT EXTRACTION DEVICE WAS FOUND BROKEN AND TWISTED. IT WAS NOTED THE BROKEN PART IS MISSING ON BOTH DEVICES. BOTH DEVICES WERE DETERMINED TO BE REPORTABLE ON (B)(6) 2016. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR ONE DOUBLE INSERT FOR EXTRACTION INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24907 DOUBLE INSERT F/EXTRACT 2+2.4 T6+T8 F/DR SCREWDRIVER HXX SYNTHES HAGENDORF 1192855

    Patients

    Seq Age Sex Outcome Treatment
    1