BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLDING+DISTRACTION INSTR F/ECD

    MDR report key: 8069435 · Received November 14, 2018

    Report

    Report Number
    8030965-2018-58206
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 5, 2018
    Report Date
    October 5, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819162617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PART: 397.127; LOT: 9831541; MANUFACTURING SITE: HAEGENDORF; RELEASE TO WAREHOUSE DATE: MARCH 07, 2016 THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL FUNCTIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SITE: CQ ZUCHWIL SELECTED FLOWS: 2. DEVICE INTERACTION/FUNCTIONAL 3. DAMAGED: VISUAL / EXAMPLES: DEFORMED/BENT/CRACKED VISUAL INSPECTION: CUSTOMER RETURNED ONE (1) PART. THE DISTAL PART OF THE INSTRUMENT IS MADE OF ONE MAIN BODY, TWO CLAMPS, AND TWO SPRINGS. THE FUNCTION OF THE CLAMPS IN COMBINATION WITH THE SPRINGS IS TO HOLD THE IMPLANT SECURE AND IN PLACE. AS SEEN, THE CATCHERS ARE 4 BENT INWARDS. BOTH CLAMPS HAVE STRONG SIGNS OF USAGE AND SCRATCHES. ON THE KNURLED KNOB ON THE PROXIMAL SIDE ARE ALSO STRONG SIGNS OF USE VISIBLE. ALL OTHER PARTS ARE IN A SOUND CONDITION AND SHOW NO SIGNS OF DAMAGE. FUNCTIONAL TEST: AS THE TWO CLAMPS ARE BENT INWARDS, THE FUNCTION OF THE INSTRUMENT IS NO LONGER GUARANTEED. A SECURE HOLD OF THE IMPLANT IS NO LONGER POSSIBLE. DIMENSIONAL INSPECTION: A DIMENSION INSPECTION OF THE RELEVANT FEATURES IS NOT POSSIBLE ANYMORE DUE THE DEFORMED CATCHERS. DRAWING/SPECIFICATION REVIEW: THE RISK MANAGEMENT FILE WAS REVIEWED, AND IT WAS FOUND THAT THE COMPLAINT CONDITION IS ADEQUATELY ADDRESSED. SUMMARY: THE COMPLAINT CONDITION CANNOT BE REPLICATED WITH THE RECEIVED HOLDING+DISTRACTION INSTRUMENT AS THE DEVICE IS IN GENERAL NOT FUNCTIONAL ANYMORE WITH THE DEFORMED CATCHERS. DUE TO THIS DAMAGE, THE COMPLAINT IS CONFIRMED, ALTHOUGH THE COMPLAINED MALFUNCTION ITSELF CANNOT BE REPLICATED ANYMORE. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT THE INSTRUMENT DID PASS THE FUNCTION TEST DURING INSPECTION AND THE VISIBLE MARKS AT THE DEFORMED LEVER CLEARLY INDICATE THAT THE DEFORMATION WAS CAUSED POST-MANUFACTURING. HOWEVER, BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE DEFINED WHEN EXACTLY THIS DEFORMATION OCCURRED; IT IS UNKNOWN IF THIS WAS DURING A PREVIOUS PROCEDURE OR DURING THE FAILED DISENGAGEMENT ATTEMPT OF THE FIRST OR THE SECOND IMPLANT. FINALLY, THE EXACT ROOT CAUSE CANNOT BE DEFINED. ONE POSSIBLE CAUSE COULD BE NOT ENOUGH SPACE NEXT TO THE IMPLANT AFTER THE INSERTION, WHICH COULD PREVENT THE MOVING/RELEASING OF THE CATCHERS. SUCH A BLOCKING WOULD ALSO LEAD TO A DEFORMATION OF THE LEVERS OF THE CATCHERS WHEN TOO MUCH FORCE IS APPLIED FOR LOOSENING. 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 · 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. REPORTER IS SYNTHES SALES REPRESENTATIVE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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) 2018, DURING AN UNKNOWN SURGERY, A HOLDING AND EXPANSION DEVICE WOULD NOT DETACH FROM AN UNKNOWN EXPANDABLE CORPECTOMY DEVICE (ECD) IMPLANT, THEREFORE CAUSING CONCERN FOR THE SURGEON. AFTER TRYING TO MANIPULATE IT IN SEVERAL WAYS TO RELEASE IT, THE IMPLANT EXPANSION MECHANISM WAS JAMMED. ANOTHER UNKNOWN IMPLANT (SLIGHTLY LARGER) HAD TO BE USED AND THE SAME ISSUE PRESENTED WITH THE HOLDING AND EXPANSION DEVICE NOT RELEASING. AFTER TRYING AGAIN FOR SOME TIME TO RELEASE THE DEVICE FROM THE IMPLANT, IT EVENTUALLY DISENGAGED. THERE WAS A SURGICAL DELAY OF ONE (1) HOUR REPORTED. IT WAS UNKNOWN IF THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT IS LINKED TO DEPUY SPINE COMPLAINTS (B)(4). THIS REPORT IS FOR ONE (1) HOLDING INSTRUMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909627 HOLDING+DISTRACTION INSTR F/ECD MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 9831541 07611819162617

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention