BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    MDR report key: 9991071 · Received April 23, 2020

    Report

    Report Number
    8030965-2020-03067
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    April 3, 2020
    Report Date
    April 3, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819968417
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT PART NUMBER: 03.614.017, LOT NUMBER: T130088, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: 30-NOV-2015. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SELECTION, INVESTIGATION SITE: TUTTLINGEN, SELECTED FLOW(S): DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE DEVICES WERE DELIVERED IN ONE SEALABLE BAG. THE DEVICES APPEAR IN GOOD CONDITION WITH A FEW SIGNS OF WEAR. THE DEVICES 03.614.036 (LOT # 8289568) AND 03.614.039 (LOT # 7542908) WERE NOT MANUFACTURED AT THE SITE TUTTLINGEN, THEREFORE THE INVESTIGATION IS ONLY CARRIED OUT FOR THE DEVICE 03.614.017 (LOT # T130088). THE CLAMPING SCREW ON THE SLEEVE IS MISSING AND THE SLEEVE IS TOO TIGHTLY SCREWED, IT CANNOT BE UNSCREWED BY HAND. FUNCTIONAL TEST: THE DEVICES CAN BE ASSEMBLED AND DISASSEMBLED. IN SOME CASES, THE DEVICE 03.614.039 (HEXAGONAL SCREWDRIVER SHAFT) REMAINS STUCK AND CANNOT BE DISASSEMBLED IMMEDIATELY. IT WAS VERY DIFFICULT TO UNSCREW THE SLEEVE, AS THERE ARE RESIDUES ON THE THREAD. ONE OF THE THREE SECURING POINTS ON THE SLEEVE OF THE COUPLING MECHANISM IS BROKEN, PROBABLY DUE TO THE FREQUENT USE OF THE DEVICE. WITHOUT THE TRIGGER HOUSING, THE DEVICE WORKS PERFECTLY. THE TRIGGER HOUSING WAS COMPLETELY SCREWED-ON AGAIN AND THE FUNCTION TEST WAS REPEATED. THE HEXAGONAL SCREWDRIVER SHAFT GOT STUCK IN SOME CASES. ACCORDING TO THE DRAWING, THE COUPLING MECHANISM SHOULD BE AT A DISTANCE OF 47MM FROM THE TRIGGER HOUSING. IN THE FULLY SCREWED-ON STATE, THE DISTANCE IS 45,8MM, THUS THE COUPLING MECHANISM IS 2MM TOO SHORT. THE TRIGGER HOUSING WAS SCREWED BACK 2MM AND THEN ALSO MATCHED THE CENTERING TIP FOR THE CLAMPING SCREW. WITH A DISTANCE OF 47MM BETWEEN TRIGGER HOUSING AND COUPLING MECHANISM, THE DEVICE WORKS PERFECTLY. DIMENSIONAL INSPECTION: THE RELEVANT DEVICE FEATURES ARE WITHIN THE REQUIRED SPECIFICATION. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURED AND CURRENT REVISIONS OF THE DRAWING WERE REVIEWED, AND NO RELEVANT DESIGN OR MANUFACTURING SPECIFICATION CHANGES WERE IDENTIFIED. SUMMARY: THE RECEIVED CONDITION OF THE HOLDING SLEEVE IS COMPLAINT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. THIS LOT WAS MANUFACTURED IN NOVEMBER 2015 ACCORDING TO THE SPECIFICATIONS. BASED ON THE FUNCTIONAL TEST, THE DEVICE WAS NOT USED IN A COMPLIANT MANNER. THE TRIGGER HOUSING SLEEVE WAS SCREWED TOO FAR, AS A RESULT THE COUPLING MECHANISM WAS NOT FULLY TRIGGERED. IN THIS STATE, DEPENDING ON THE POSITION OF THE SPRING IN THE MECHANISM, ONE OF THE BALLS IS PROBABLY NOT COMPLETELY RELEASED AND THE HEXAGONAL SCREWDRIVER SHAFT CLAMPS WHEN PULLING OUT. UNDER THE CORRECT CONDITIONS, THE DEVICE WORKS PERFECTLY. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO PRODUCT DESIGN OR MANUFACTURING ISSUES WAS FOUND DURING INVESTIGATION, THEREFORE NO PRM DOCUMENTS WERE REVIEWED. 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

    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 ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL SPINAL FUSION IN C1-C2 TREATING ATLANTOAXIAL SUBLUXATION ON (B)(6) 2020. THEY HAD NO ISSUE ON ASSEMBLING THE HOLDING SLEEVE, THE SLIP SLEEVE, THE SCREWDRIVER SHAFT, AND USING THE UNIT DURING THE PROCEDURE. HOWEVER, THEY WERE NOT ABLE TO DISASSEMBLE THOSE DEVICES. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME WAS 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
    453133 THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH T130088 07611819968417

    Patients

    Seq Age Sex Outcome Treatment
    1 HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED| HOLD-SL| OUTERSLEEVE F/HOLDING SLEEVE NO. 03.614.