BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS

    MDR report key: 8383461 · Received March 1, 2019

    Report

    Report Number
    8030965-2019-61651
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    February 6, 2019
    Report Date
    February 7, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWB
    UDI-DI
    07611819018457
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. ADDITIONAL NARRATIVE: H3, H4, H6- VISUAL INSPECTION:THE MAJORITY OF THE THREADED CONICAL PART IS BROKEN OFF DIAGONALLY. NO FRAGMENTS WERE RETURNED FOR INVESTIGATION. DIMENSIONAL INSPECTION: DUE DUE THE DAMAGE THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE. MATERIAL/HARDNESS REVIEW: THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT WITH 1.4112 STAINLESS STEEL THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION SUMMARY: THE COMPLAINT IS CONFIRMED AS THE EXTRACTION SCREW IS BROKEN AS COMPLAINED. THIS LOT WAS MANUFACTURED IN AUGUST 2018, ALL DEVICES ARE SHIPPED AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER COMBINATION. BASED ON THAT AND THE FINDINGS ABOVE A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. BASED ON THE PROVIDED INFORMATION THE EXACT CAUSE OF THE BREAKAGE CAN NOT BE DEFINED. IT CAN ONLY BE ASSUMED THAT A MECHANICAL OVERLOAD DURING THE EXTRACTION OF A POSSIBLY BLOCKED SCREW DID LEAD TO THE BREAKAGE. 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: 309.530, LOT: L961662, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: (B)(6)2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MATERIAL 1.4112 WAS USED WITH CORRECT HARDNESS AFTER PROCEDURE AND DOCUMENTED. ADDITIONAL DATA-D10: 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

    OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATION. THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE CONICAL EXTRACTION SCREW BROKE DURING A REMOVAL SURGERY. THE SURGEON CONFIRMED THROUGH X-RAYS THAT THERE WAS NO FRAGMENT LEFT IN THE PATIENT'S BODY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174343 CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS EXTRACTOR HWB OBERDORF SYNTHES PRODUKTIONS GMBH L961662 07611819018457

    Patients

    Seq Age Sex Outcome Treatment
    1