BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CANCELLOUS POLYAXIAL SCREW 34MM

    MDR report key: 8972434 · Received September 6, 2019

    Report

    Report Number
    8030965-2019-68072
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 10, 2019
    Report Date
    August 10, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKG
    UDI-DI
    07611819969254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H4, H6: PART: 04.614.234S LOT: 8063816 MANUFACTURING SITE: SELZACH SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG RELEASE TO WAREHOUSE DATE: 12. SEP. 2012 EXPIRY DATE: 01. SEP. 2022 DEVICE WAS FIRST MANUFACTURED UNSTERILE UNDER THE LOT 6959456 IN BRANDYWINE AND STERILIZED AFTERWARDS. AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED ONLY THE MANUFACTURING DOCUMENTS OF THE UNSTERILE DEVICE 04.614.234 WITH LOT 6959456 NEED TO BE REVIEWED. PART NUMBER 04.614.234 LOT NUMBER: 6959456 DATE OF MANUFACTURE: 06-07-2012 PLACE OF MANUFACTURE: BRANDYWINE PLANT. PART EXPIRATION DATE: N/A (NONSTERILE) THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO NONCONFORMANCE'S OR ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SITE: CQ ZUCHWIL SELECTED FLOW: DEVICE INTERACTION/FUNCTIONAL VISUAL INSPECTION: THE COMPLAINT CONDITION COULD BE CONFIRMED AS THE NEUTRAL BODY, BUSHING AND SLEEVE HAVE SEPARATED FROM THE SCREW. ADDITIONALLY, THE STAR DRIVE ON THE SCREW IS STRONGLY DAMAGED AND THE SLEEVE INSIDE THE BODY IS DEFORMED. FUNCTIONAL TEST: IT IS NOT POSSIBLE TO PERFORM A FUNCTIONAL TEST AS THE NEUTRAL BODY, BUSHING AND SLEEVE HAS SEPARATED FROM EACH OTHER. THE SLEEVE IS ALSO DEFORMED THEREFORE IT IS NOT POSSIBLE TO PERFORM A FUNCTIONAL TEST. DIMENSIONAL INSPECTION: DUE TO POST MANUFACTURING DAMAGE AN ACCURATE DIMENSIONAL INSPECTION COULD NOT BE OBTAINED. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SUMMARY: THE RECEIVED CONDITION OF THE PART IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. THIS LOT WAS MANUFACTURED IN (B)(6) 2012 ACCORDING TO THE SPECIFICATION. THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LET TO THIS OCCURRENCE. BASED ON THE VISIBLE DAMAGES INSIDE THE STAR DRIVE WE MUST ASSUME THAT HIGH LATERAL FORCE WAS APPLIED DURING THE ATTEMPTING OF REMOVING THE SCREWDRIVER FROM THE SCREW HEAD, WHICH FINALLY HAS LET DO THE SEPARATION OF THE PARTS. 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. H6: METHOD, RESULTS, AND CONCLUSION CODES HAVE BEEN UPDATED PER THE COMPLETION OF THE INVESTIGATION. 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

    ADDITIONAL PRODUCT CODES: KWP, MNH, MNI. 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 A POSTERIOR CERVICAL FUSION PROCEDURE TREATING TUMOR OCCURRED ON (B)(6) 2019. AFTER THE SCREW WAS INSERTED, THE SURGEON TRIED TO DETACH THE SCREW FROM A SCREWDRIVER. THEN, THE SCREW HEAD CAME OFF. THE FRAGMENT WAS REMOVED FROM THE PATIENT¿S BODY. THE SURGEON COMPLETED THE PROCEDURE WITH A REPLACEMENT LESS THAN A 30-MINUTE DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765793 4.5MM TI CANCELLOUS POLYAXIAL SCREW 34MM ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG OBERDORF SYNTHES PRODUKTIONS GMBH 6959456 07611819969254

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SCREWDRIVERS: SPINE