BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 12342761 · Received August 19, 2021

    Report

    Report Number
    8030965-2021-06856
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 21, 2021
    Report Date
    July 21, 2021
    Manufacturer
    RTI SURGICAL
    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. H3, H6: PART: 391.201, LOT: P360007, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 08 APRIL 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO US CUSTOMER QUALITY (CQ) FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT CABLE TENSIONER NO VISUAL ISSUES WERE IDENTIFIED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO ALLEGED COMPLAINT CONDITION. THE FUNCTIONAL TEST WAS DONE BY THE RTI SURGICAL STATES THAT INSPECTION WAS PASSED PER FUNCTIONAL INSPECTION PASSED. THE OBSERVED CONDITION OF CABLE TENSIONER IN THE DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR CABLE TENSIONER. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED? THE FOLLOWING DRAWING REFLECTING THE CURRENT AND MANUFACTURE REVISION WAS REVIEWED: CABLE TENSIONER ORTHOPAEDIC CABLE SYSTEM. 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

    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. 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 COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR SUPRACONDYLAR FRACTURE OF THE FEMUR WITH CERCLAGE CABLE. DURING THE SURGERY, TENSION WAS APPLIED TO THE CABLE TO SOME EXTENT AROUND THE 50 KG MARK ON THE CABLE TENSIONER, BUT THE DOCTOR APPLIED TENSION TO ABOUT 60 KG IN ORDER TO TIGHTEN IT MORE, AND AFTER THAT TENSION WAS NOT APPLIED. IT WAS FOUND THAT THE CABLE WAS ABOUT TO BE CUT NEAR THE TIP OF THE CABLE TENSIONER. EVEN WHEN THE GOLD KNOB OF THE CABLE TENSIONER WAS TURNED COUNTERCLOCKWISE AS MUCH AS POSSIBLE, THE TENSION HOLDER CAME OFF ONLY A LITTLE AND THE CABLE COULD NOT BE REMOVED FROM THE CABLE TENSIONER. THE CERCLAGE CABLE WAS CUT AT THE AREA AROUND THE BONE, AND AFTER REMOVING IT FROM THE OPERATIVE FIELD, THE ATTACHMENT WAS REMOVED ONE BY ONE. THE CABLE WAS ALSO REMOVED. THE PERIPROSTHETIC SCREW WAS INSERTED IN THE PART WHERE THE CABLE COULDN'T BE WOUND. IT WAS CONFIRMED THAT THERE WAS NO PROBLEM WITH FIXATION AND THERE WAS NO EFFECT ON PATIENT. THE OTHER CERCLAGE CABLE HAD ALREADY BEEN ROLLED UP SMOOTHLY BEFORE THIS EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO MORE THAN A THIRTY (30) MINUTE DELAY. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239093 CABLE TENSIONER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH RTI SURGICAL P360007 07611819719811

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - CABLE/WIRE: TRAUMA| UNK - DRILL BITS: TRAUMA| UNK - SCREWS: TRAUMA| UNK - TENSIONING INSTRUMENTS: TRAUMA| UNK - CABLE/WIRE: TRAUMA.| UNK - DRILL BITS: TRAUMA.| UNK - SCREWS: TRAUMA.| UNK - TENSIONING INSTRUMENTS: TRAUMA.