BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® COUPLING SCREW

    MDR report key: 8784960 · Received July 12, 2019

    Report

    Report Number
    8030965-2019-66199
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 7, 2019
    Report Date
    June 13, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWB
    UDI-DI
    07611819022133
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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, H4, H6: PART 338.310, LOT 8439855: MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: JUNE 12, 2013. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL INSPECTION OBSERVED THAT THE THREADED, DISTAL END OF THE SHAFT OF THE CONNECTING SCREW (338.310) WAS BROKEN OFF AND THAT THE DEVICE HAD MINIMAL SURFACE WEAR. THE BROKEN PART IS STILL JAMMED IN THE DHS/DCS SCREW. THE DHS/DCS SCREW WAS FOUND IN A USED CONDITION SUCH AS SCRATCHES ON THE SURFACE. NO FURTHER DAMAGES ON BOTH DEVICES VISIBLE. THE RELEVANT FEATURES ARE HEAVY DAMAGED IN A MANNER WHICH PREVENTS ACCURATE MEASUREMENT OF THE FEATURES. MOREOVER, THE BROKEN PART CANNOT BE REMOVED FROM THE SCREW AND DOES NOT ALLOW ANY DIMENSIONAL MEASUREMENT AS WELL. OUR INVESTIGATION HAS SHOWN THAT THE COMPLAINT CONDITION FOR THE RECEIVED DEVICE IS CONFIRMED DUE TO THE BREAKAGE. IT IS LIKELY THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES, SUCH AS EXCESSIVE FORCE APPLICATION DURING ITS USE, WHICH FINALLY RESULTED IN THE BREAKAGE OF THE TIP AND THE JAMMING OF THE BROKEN PART. DURING THE INVESTIGATION ON BOTH DEVICES, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. FURTHERMORE, BY THE EVIDENCE THAT THE CONNECTING SCREW (338.310) WAS SUCCESSFULLY USED DURING ITS 5 (FIVE) YEARS OF LIFESPAN AND POST MANUFACTURING WEAR DAMAGES WERE IDENTIFIED, WE FINALLY CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE'S. THE ROOT CAUSE WAS IDENTIFIED DURING THE PERFORMED EVALUATION AND THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. 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 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

    (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, 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 THAT ON (B)(6) 2019, DURING AN UNKNOWN SURGERY FOR A FEMORAL COLAR FRACTURE, THE SCREW THREAD OF A CONNECTING SCREW FOR DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) BROKE ON THE DHS/DCS SCREW. A BACK-UP CONNECTING SCREW WAS USED. THERE WAS A SURGERY DELAY OF AN UNKNOWN MINUTES AS THE SURGEON HAD TO IMPLANT ANOTHER SCREW. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579574 DHS®/DCS® COUPLING SCREW EXTRACTOR HWB OBERDORF SYNTHES PRODUKTIONS GMBH 8439855 07611819022133

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR