BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 9891394 · Received March 27, 2020

    Report

    Report Number
    8030965-2020-02369
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Report Date
    March 2, 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 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. 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

    REPORTER IS COMPANY REPRESENTATIVE. INVESTIGATION SUMMARY. PICTURE REVIEW: NARRATIVE (DRIVING CAP BROKEN AND THREADED TIP STUCK IN INSERTION HANDLE) COULD BE VERIFIED FROM PROVIDED PICTURES. INVESTIGATION SITE: CQ ZUCHWIL SELECTED FLOW: DAMAGED - BROKEN VISUAL INSPECTION: THE THREADED PART OF THE DRIVING CAP IS BROKEN OFF BELOW THE LAST THREAD FLANK. THE REMAINING THREAD FLANK IS TOTALLY FLATTENED, THE BLACK COATING IS NOT PRESENT ANYMORE AT THE DAMAGE. THE BROKEN OFF PART IS STILL STUCK IN THE RECEIVING INSERTION HANDLE AND CANNOT BE REMOVED. 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: DRAWING SE_380067 REVISION K 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. 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 THE PROVIDED INFORMATION ¿ DAMAGE NOTED DURING LOAN KIT INSPECTION - WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. HOWEVER, IT IS MOST LIKELY THAT ANY UNINTENDED EXCESSIVE FORCES DURING USE HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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. DEVICE HISTORY LOT PART: 03.010.523 LOT: L052029 MANUFACTURING SITE: BETTLACH RELEASE TO WAREHOUSE DATE: OCT. 06, 2016 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.

    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 DRIVING CAP/THREADED AND RADIOLUCENT INSERTION HANDLE FRN WAS DAMAGED. IT WAS UNKNOWN IF THERE WAS ANY SURGERY INVOLVED. THE PATIENT STATUS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354625 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH L052029 07611819499188

    Patients

    Seq Age Sex Outcome Treatment
    1 DRIVING CAP F/INSERTION HANDLE| INSERT-HANDLE RADIOLUC FEM RECON NAIL