BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 6193176 · Received December 21, 2016

    Report

    Report Number
    1719045-2016-10937
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    November 30, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    10886982198204
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE 3RD PARTY CABLE GOT STUCK IN THE TENSIONER, AND WHEN REMOVED THE TENSIONER BROKE. THE REPAIR TECHNICIAN REPORTED THE NOSE PIECE WAS BROKEN. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WAS SENT TO THE VENDOR FOR REPAIR ON (B)(6) 2017. THE VENDOR REPORTED THE NOSE PIECE WAS MISSING. THE VENDOR REPAIRED THE DEVICE PER THE VENDOR WORK INSTRUCTIONS. THE DEVICE WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS CONFIRMED. 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

    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 391.201 WITH LOT NUMBER(S) P304225 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 16-FEB-2004. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. ADDITIONAL MANUFACTURE DATES OF THIS ITEM ARE 3-MAR-2004, 5-MAR-2004. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NCRS WERE GENERATED DURING PRODUCTION. DHR REVIEW FOR PART #391.201, LOT #P304225. RELEASE TO WAREHOUSE DATE: 16-FEB-2004, 03-MAR-2004, 05-MAR-2004. EXPIRATION DATE: N/A. SUPPLIER: (B)(4). 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

    THE SERVICE & REPAIR DEPARTMENT DOCUMENTED THAT THE CUSTOMER HAD USED TWO (2) CABLE TENSIONERS TO TENSION EIGHT (8) STRYKER 2.0 CABLES. THE CABLE GOT STUCK IN THE TENSIONERS. THEY WERE UNABLE TO GET THE CABLE OUT OF THE TENSIONER SO THEY CUT THE CABLE. NO KNOWN IMPACT OR CONSEQUENCE IN THE SURGERY. CONCOMITANT DEVICE REPORTED: STRYKER CABLE 2.0 (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS IS REPORT NUMBER 1 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844959 CABLE TENSIONER MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT P304225 10886982198204

    Patients

    Seq Age Sex Outcome Treatment
    1 STRYKER CABLE 2.0 (PART # UNKNOWN)