BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 10541508 · Received September 16, 2020

    Report

    Report Number
    8030965-2020-07075
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Report Date
    August 20, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819499188
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A J&J EMPLOYEE. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE THREADED PART OF THE DRIVING CAP IS BROKEN OFF BELOW THE LAST THREAD FLANK. THE BROKEN OFF PART IS STILL STUCK IN THE ALSO RECEIVED INSERTION HANDLE AND CANNOT BE REMOVED. THERE ARE SOME ABRADED AREAS ON THE FRACTURE SURFACE VISIBLE. IN GENERAL, THE DRIVING CAP PRESENTS HAMMER MARKS (DENTS) FROM HAMMERING; OTHERWISE, THE PART IS IN A GOOD CONDITION. DIMENSIONAL INSPECTION: THE RELEVANT DIMENSIONS CANNOT BE VERIFIED DUE TO THE DAMAGE INCURRED. DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWING WAS REVIEWED DURING THIS INVESTIGATION. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT WITH 1.4542 STAINLESS STEEL THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION PER RELEVANT DRAWING. INSPECTION SHEET OF THIS LOT PASS ALL INSPECTION STEPS DURING MANUFACTURING WITHOUT ANY DEVIATIONS. SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS THE THREADED TIP OF THE DRIVING CAP IS BROKEN OFF. THIS PRODUCTION LOT (L052029) WAS MANUFACTURED IN OCTOBER 2016 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THE CORRECT MATERIAL WAS USED, AND THE HARDNESS PARAMETERS WERE WITHIN THE SPECIFICATIONS. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. BASED ON THESE FINDINGS WE HAVE TO ASSUME THAT THERE WAS A LOOSE OR INSUFFICIENT CONNECTION WITH THE INSERTION HANDLE. PLEASE NOTE, IN ORDER TO ENSURE A CORRECT LOAD TRANSFER, IT IS CRUCIAL TO HAVE AN APPROPRIATE CONNECTION AND THE DRIVING CAP SHOULD BE TIGHTEN WITH THE RATCHET WRENCH. (SEE ALSO SURGICAL TECHNIQUE (B)(4)). FURTHERMORE, ABRADED AREAS WERE OBSERVED ON THE FRACTURE SURFACE, WHICH WERE CAUSED BY HITTING OF THE TWO BROKEN PARTS AGAINST EACH OTHER, AFTER THE THREADED TIP HAD BROKEN. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.010.523, LOT: L052029, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: (B)(4) 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS NOTICED THAT THE THREAD OF DRIVING CAP/ THREADED HAS SNAPPED OFF AND HAS LODGED WITHIN RADIOLUCENT INSERTION HANDLE FRN. NO KNOWN PATIENT OR CASE INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007450 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH L052029 07611819499188

    Patients

    Seq Age Sex Outcome Treatment
    1 INSERT-HANDLE RADIOLUC FEM RECON NAIL