BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 7932242 · Received October 3, 2018

    Report

    Report Number
    8030965-2018-56981
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    September 12, 2018
    Report Date
    September 12, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819719811
    PMA / PMN Number
    EXEMPT
    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. DHR REVIEW WAS COMPLETED. PART NUMBER: 391.201. SYNTHES LOT NUMBER: P141349. SUPPLIER LOT NUMBER: P141349. RELEASE TO WAREHOUSE DATE: 12-FEB-2013. MANUFACTURING SITE: SYNTHES MONUMENT. SUPPLIER: PIONEER SURGICAL TECHNOLOGY. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. INVESTIGATION SITE: CQ ZUCHWIL. SELECTED FLOW: 2. DEVICE INTERACTION/FUNCTIONAL - UNABLE TO DISASSEMBLE. VISUAL INSPECTION: OUR INVESTIGATION HAS SHOWN THAT A CABLE IN THE CABLE TENSIONER IS COMPLETELY JAMMED. ALSO, ITS VISIBLE THAT SEVERAL CORDS OF THE CABLE ARE JAMMED IN THE GRIPPING MECHANISM (CLAMPING JAWS). FUNCTIONAL TEST: DURING OUR INVESTIGATION, THE CABLE COULD ALSO NOT BE REMOVED BY TRYING TO TURN THE KNOB COUNTERCLOCKWISE AT THE END OF THE TENSIONER. DIMENSIONAL INSPECTION: BECAUSE OF THE JAMMED CABLE THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS ANYMORE. DRAWING/SPECIFICATION REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SUMMARY: THE COMPLAINT CONDITION CAN BE CONFIRMED, DUE TO EVIDENCE THAT THE CABLE IS JAMMED IN THE CABLE TENSIONER. AFTERWARDS AND WITHOUT ANY FURTHER DETAILS, IT IS UNFORTUNATELY NOT POSSIBLE TO DETERMINE THE EXACT CAUSE FOR THIS JAMMING. WE ONLY CAN ASSUME THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. PLEASE NOTE OUR OP INSTRUCTIONS. "...TURN THE FLUTED KNOB AT THE END OF THE TENSIONER COUNTERCLOCKWISE AS FAR AS POSSIBLE, THUS THE INSERTION / REMOVAL OF THE CABLE IS GUARANTEED". IN THIS REGARD, ALTERNATIVELY THE NEW CABLE TENSIONER 03.221.015 (ONE-HAND OPERABLE CABLE TENSIONER) CAN ALSO BE USED. DURING THE INVESTIGATION NO MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    Description of Event or Problem · 0

    CONCOMITANT DEVICE: LCP DISTAL FEMUR PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN).

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. DICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR A PERIPROSTHETIC FEMORAL FRACTURE ON (B)(6) 2018. THE PROCEDURE WAS PERFORMED WITH LOCKING COMPRESSION PLATE (LCP) DISTAL FEMUR PLATE. DURING SURGERY, WHEN THE SURGEON INSERTED THE CABLE INTO THE CABLE TENSIONER, IT DIDN'T COME OUT FROM THE OTHER SIDE OF THE TENSIONER. THE CABLE COULD NOT BE TENSIONED. AFTER TRYING TO APPLY THE TENSION, THE CABLE COULD NOT BE PULLED OUT NOR BE MOVED FORWARD. THE SURGERY WAS FINISHED BY CUTTING THE CABLE AND USING ANOTHER SOFT WIRE. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS FOR TWO (2) DEVICES. THIS COMPLAINT INVOLVES ONE (1) CABLE TENSIONER. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770123 CABLE TENSIONER MISC ORTHO SURGICAL INSTRUMENT LXH OBERDORF SYNTHES PRODUKTIONS GMBH P141349 07611819719811

    Patients

    Seq Age Sex Outcome Treatment
    1