BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER WITH PISTOL GRIP

    MDR report key: 6779046 · Received August 9, 2017

    Report

    Report Number
    1719045-2017-10749
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 15, 2017
    Report Date
    July 15, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    10886982076748
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE & DOB NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DATE RETURNED TO MANUFACTURER. 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 THE: PART # 03.221.015 AND LOT # P170466, DHR REVIEW FOR PART: #03.221.015 -SYNTHES LOT #P170466, RELEASE TO WAREHOUSE DATE: 17JAN2014, EXPIRATION DATE: NA, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    PATIENT ID (B)(6). PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. A DEVICE HISTORY RECORDS(DHR) REVIEW, DEVICE INSPECTION, FUNCTIONAL TEST AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. UPON VISUAL INSPECTION, THE INSTRUMENT OPERATED AS INDICATED. HOWEVER, CONCOMITANT CABLES WERE NOT RETURNED NOR AVAILABLE FOR COMPLAINT REPLICATION. THE DEVICE IS IN GOOD CONDITION, NO DAMAGE WAS NOTED, AND NO ISSUES AROSE THAT WOULD INTERFERE WITH DEVICE FROM MATING WITH ITS CABLE COMPONENTS. THIS COMPLAINT IS UNCONFIRMED. RELEVANT DRAWING WAS REVIEWED AND THE RETURNED DEVICE WAS DETERMINED TO BE ACCEPTABLE PER THE DRAWING SPECIFICATION. THE INSTRUMENT OPERATED AS INTENDED. NO DEFINITE ROOT CAUSE CAN BE DETERMINED DUE TO THE COMPLAINT CONDITION BEING UNCONFIRMED AND THE DEVICE OPERATING AS INDICATED. 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

    IT WAS REPORTED THAT THE SPRING LOADED RELEASE MECHANISM ON THE CABLE TENSIONER WOULD NOT RELEASE DURING A PROCEDURE ON (B)(6) 2017. WHEN THE SURGEON TRIED TO TENSION THE CABLE WITH THE PISTOL GRIP TENSIONER, HE WAS HAVING TROUBLE WITH THE TENSIONER, AS THE SPRING LOADED MECHANISM WOULD NOT UNLOCKING, WHICH WAS NOT ALLOWING SURGEON TO ACTUALLY TENSION THE CABLE. THE SURGEON COULD NOT GET THE CABLE OFF FOR A WHILE; WHEN HE DID, THE CABLE WAS NOT TENSIONED. THE SURGEON USED ANOTHER TENSIONER. SURGICAL DELAY IS 13-15 MINUTES AND PATIENT OUTCOME IS UNKNOWN. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT DEVICES REPORTED: CABLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557920 CABLE TENSIONER WITH PISTOL GRIP MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT P170466 10886982076748

    Patients

    Seq Age Sex Outcome Treatment
    1