BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE/ LARGE WITH QUICK COUPLING

    MDR report key: 9627166 · Received January 24, 2020

    Report

    Report Number
    8030965-2020-00599
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Date of Event
    January 4, 2020
    Report Date
    January 6, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWX
    UDI-DI
    07611819499126
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 03.010.516. LOT NUMBER: T120595. MANUFACTURING SITE: TUTTLINGEN. RELEASE TO WAREHOUSE DATE: 18-MAR-2016. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 THAT ON (B)(6) 2019, THE PATIENT GOT THE RIGHT FEMORAL NECK FRACTURE (GARDEN) BY AN UNKNOWN REASON. ON THE SAME DAY, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY WITH A FEMORAL NECK SYSTEM (FNS). PATIENT MADE GOOD PROGRESS AFTER THE OPERATION. HOWEVER, THE PATIENT FELL ON (B)(6) 2020 AND GOT RIGHT FEMORAL SUBTROCHANTERIC FRACTURE AND LEFT PROXIMAL HUMERAL FRACTURE. ON THE SAME DAY, THE PATIENT UNDERWENT REOPERATION AND THE FNS WAS REPLACED BY TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WITH THE PURPOSE OF FIXING THE SUBTROCHANTERIC FRACTURE. THERE WAS NO DISPOSITION IN THE FEMORAL NECK FRACTURE. DURING THE REOPERATION, THE SURGEON HAD DIFFICULTY IN REMOVING THE LOCKING SCREW WITH A SCREWDRIVER SHAFT AND A HANDLE BECAUSE THE TORQUE WAS INSUFFICIENT. HE USED ANOTHER SCREWDRIVER SHAFT INSTEAD AND REMOVED THE SCREW SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES THE INTRAOPERATIVE DIFFICULTY IN REMOVAL OF IMPLANTS USING A SCREWDRIVER SHAFT AND A HANDLE, WHILE RELATED COMPLAINT (B)(4) CAPTURES THE REVISION SURGERY PERFORMED ON (B)(6) 2020 DUE TO SECOND FRACTURE. CONCOMITANT DEVICE REPORTED: LOCKING SCREW (PART# 412.212S, LOT# L755620, QUANTITY 1). THIS REPORT IS FOR ONE (1) HANDLE/LARGE WITH QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92762 HANDLE/ LARGE WITH QUICK COUPLING TAP,BONE HWX OBERDORF SYNTHES PRODUKTIONS GMBH T120595 07611819499126

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR