BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE

    MDR report key: 9632934 · Received January 27, 2020

    Report

    Report Number
    8030965-2020-00669
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Report Date
    January 7, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    07611819019850
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: PART: 314.130, LOT: 9026336, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 16. SEP. 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: ALMOST THE COMPLETE HEXAGON OF THE SCREWDRIVER WITH T-HANDLE IS BROKEN OFF. THE FRAGMENT WAS NOT RETURNED FOR EVALUATION. THE REMAINDER OF THE HEXAGON IS STRONGLY TWISTED IN COUNTER-CLOCKWISE DIRECTION. THE FRACTURE FACE IS HOMOGENOUS AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. DIMENSIONAL INSPECTION: THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE AS THE REMAINDER OF THE HEXAGON IS STRONGLY DEFORMED, WHICH MAKES AN ACCURATE MEASUREMENT IMPOSSIBLE. DRAWING/SPECIFIACTION REVIEW: DRAWING FOR THE INSERT HEX 3.5 WERE REVIEWED TO VERIFY DIMENSIONS, MATERIAL AND HARDNESS OF THE DEVICE. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT WITH 1.4923 STAINLESS STEEL THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION. ALSO THE RELEVANT DIMENSIONS OF THE HEXAGON WERE VERIFIED DURING THE INSPECTION OF THE INSERT. REMARK: THE SUB-COMPONENT 12028 IS NOT LOT TRACKED. THEREFORE THE LAST TWO POTENTIAL WORK ORDERS (9122337 AND 9107411) THAT WERE PRODUCED PRIOR TO LOT 9026336 WERE REVIEWED. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED AS THE HEXAGON IS BROKEN OF AS COMPLAINED. DURING THE PERFORMED EVALUATION NO MANUFACTURING RELATED ISSUE COULD BE DETECTED. BASED ON THE APPEARANCE OF THE HEXAGON REMAINDER WE HAVE TO ASSUME THAT A MECHANICAL OVERLOAD DURING THE LOOSENING OF A POSSIBLE BLOCKED SCREW DID FIRST LEAD TO A DEFORMATION OF THE HEXAGON AND FINALLY TO A FORCED RUPTURE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. COMPLAINT IS CONFIRMED AS WE ARE ABLE TO CONFIRM COMPLAINT DESCRIPTION (THAT THE HEX HAS SNAPPED OFF) BASED ON THE RECEIVED PICTURES. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE (INFORMATION OR/AND MATERIAL), THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT PART: 314.130, LOT: 9026336, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: SEP. 16, 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS SYNTHES EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE HEX TIGHTENING HANDLE OF 314.130 SCREWDRIVER HAS SNAPPED OFF. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98014 LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE SCREWDRIVERS HXX OBERDORF SYNTHES PRODUKTIONS GMBH 9026336 07611819019850

    Patients

    Seq Age Sex Outcome Treatment
    1