BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH QUICK COUPLING- SMALL

    MDR report key: 5930764 · Received September 6, 2016

    Report

    Report Number
    2520274-2016-14437
    Event Type
    Malfunction
    Date Received
    September 6, 2016
    Date of Event
    August 12, 2016
    Report Date
    August 15, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    OVE
    PMA / PMN Number
    K093762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; THEREFORE, NO CONCLUSION COULD BE DRAWN 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: PART 03.617.903 LOT 1972822, MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 27. AUG. 2008. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: THE COMPLETE COUPLING PIECE IS SEPARATED FROM THE HANDLE AS THE DEVICE IS BROKEN APART AT THE CROSSOVER. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND; THIS DEVICE WAS MANUFACTURED IN AUGUST 2008 ACCORDING TO THE SPECIFICATION. THE INVESTIGATION HAS SHOWN THAT THE COUPLING PIECE WAS ABOUT 1.5MM UNSCREWED FROM THE HANDLE BEFORE IT BROKE. DUE TO THIS GAP BETWEEN COUPLING AND HANDLE THE FULL FORCE WAS APPLIED ONTO THE PIERCED SHAFT INSTEAD ONTO THE SUPPORTING SURFACES. THIS LEAD TO THE BREAKAGE OF THE PIERCED SHAFT AS THE LOAD WAS NOT TRANSFERRED ONTO THE SUPPORTING SURFACES AS DESIGNED. AFTERWARDS IT IS NOT POSSIBLE TO DETERMINE WHAT DID LEAD TO THE UNSCREWING OF THE COUPLING PIECE, WHICH WAS FIXED WITH SCREW SECURING ADHESIVE. THE AGE OF THE DEVICE SPEAKS AGAINST A MANUFACTURING RELATED ISSUE. IT IS LIKELY THAT AT ANY TIME, MAY BE DURING A PREVIOUS PROCEDURE, HIGH TORQUE WAS APPLIED TO LOOSEN A POSSIBLY BLOCKED SCREW, WHICH COULD LEAD TO THE UNSCREWING OF THE COUPLING PIECE. SINCE THE MANUFACTURE OF THIS DEVICE, A DESIGN CHANGE HAS OCCURRED; NOW THE COUPLING PIECE IS WELDED ONTO THE HANDLE. BY THIS AN UNSCREWING AND FINALLY A BREAKAGE LIKE IN THIS CASE IS NOT POSSIBLE ANYMORE. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HANDLE WITH QUICK COUPLING BROKE INTO TWO PIECES WHEN THE SURGEON WAS INSERTING A SCREW. THERE WAS NO HARM TO THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY WITH ONLY MINIMAL DELAY, DUE TO THE FACT THAT THERE WAS A SECOND HANDLE IN THE SET. ALL BROKEN OFF PIECES WERE REMOVED FROM THE PATIENT. THE SURGERY WAS PROLONGED ABOUT 5 MINS. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT REPORTED PART: 1X SHAFT (PART AND LOT UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    ON 15AUG2016 UPDATE: THERE IS NO PATIENT OR CO-MORBIDITY DATA AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580722 HANDLE WITH QUICK COUPLING- SMALL INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES HAGENDORF 1972822

    Patients

    Seq Age Sex Outcome Treatment
    1 1X SHAFT (PART AND LOT UNKNOWN)