BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACT-SCREW CONI F/SCR Ø4.5+6.5

    MDR report key: 9257031 · Received October 30, 2019

    Report

    Report Number
    8030965-2019-69837
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    October 11, 2019
    Report Date
    October 11, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWB
    UDI-DI
    07611819018457
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    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. VISUAL INSPECTION: THE VISUAL INSPECTION OF THE RETURNED EXTRACTION SCREW HAS SHOWN THAT THE THREADED TIP SECTION IS PARTLY BROKEN OFF. THE BROKEN OFF PART WAS NOT RETURNED FOR EVALUATION. DIMENSIONAL INSPECTION: MEASUREMENT OUTER DIAMETER Ø5.0: DRAWING, GAGE: 3-03-17585, TOLERANCE Ø5.0 0/-0.1, RESULT: Ø4.96 "PASS." DOCUMENT/SPECIFICATION REVIEW: THE USED MATERIAL WAS STAINLESS STEEL 1.4112 AS REQUIRED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. SUMMARY: THE RECEIVED CONDITION OF THE CERCLAGE PASSER IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. THIS LOT WAS MANUFACTURED IN FEBRUARY 2014 ACCORDING TO THE SPECIFICATION. BASED ON THAT AND THE CONDITION OF THE ITEM A PRODUCT RELATED ISSUE CAN BE EXCLUDED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THE BREAKAGE. WE ONLY CAN ASSUME THAT A MECHANICAL OVERLOAD SITUATION DURING REMOVAL HAS LED TO THE BREAKAGE. BASED ON THE MANUFACTURING INVESTIGATION RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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: PART: 309.530, LOT: 8800678, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 26. FEB. 2014. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. UPDATED INITIAL REPORTER AND REPORTER'S STATE: (B)(6). 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 · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW / INVESTIGATION BUT HAS YET TO BE RECEIVED. (B)(4). 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 AN UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY WITH FEMORAL NECK SYSTEM (FNS). ON AN UNKNOWN DATE, THE PSEUDARTHROSIS WAS FOUND. ON (B)(6) 2019, A REOPERATION TO REMOVE FNS AND TOTAL HIP ARTHROPLASTY WAS OPERATED. DURING THE REOPERATION, THE SURGEON COULD NOT REMOVE THE LOCKING SCREW IN QUESTION AND USED THE EXTRACTION SCREW. HOWEVER, THE EXTRACTION SCREW GOT BROKEN IN THE SCREWHEAD. THE FRAGMENT AND SCREWHEAD WERE REMOVED BY USING AN AIRTOME (SURGICAL INSTRUMENT) AND THE SCREW WAS EXTRACTED DURING DRILLING OF THE BONE WITH A HOLLOW REAMER. THE SURGERY WAS DELAYED BY 45 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES THE EVENT ON (B)(6) 2019¿S REOPERATION WHILE THE RELATED COMPLAINT (B)(4) CAPTURES THE PSEUDARTHROSIS EVENT AFTER THE INITIAL SURGERY. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW F/SCR Ø4.5+6.5. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052036 EXTRACT-SCREW CONI F/SCR Ø4.5+6.5 EXTRACTOR HWB OBERDORF SYNTHES PRODUKTIONS GMBH 8800678 07611819018457

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention