BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE CUTTER-STANDARD

    MDR report key: 4868781 · Received June 25, 2015

    Report

    Report Number
    9680938-2015-10055
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 15, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS PENDING COMPLETION. DEVICE 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

    ADDITIONAL NARRATIVE: DEVICE HISTORY REVIEW: MANUFACTURING DATE: MAY 16, 2013. 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. THE RAW MATERIALS, WHICH WERE DELIVERED AS LOT 7344306 (FOR CARBIDE INSERTS), KR91879 (FOR BODY), AND KR87611 (FOR THE JAWS) ARE CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF MANUFACTURING BETWEEN 48.2-48.8 HRC FOR 1.4021 AND WAS FOUND TO BE GOOD. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. DEVICE 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

    ADDITIONAL NARRATIVE: A DEVICE EVALUATION INVESTIGATION WAS PERFORMED: ONE CABLE CUTTER, STANDARD (PART NUMBER 391.905, LOT NUMBER T990483) WAS RECEIVED WITH THE COMPLAINT THAT ONE OF THE TIP BLADES WAS MISSING WHEN IT CAME OUT OF THE SET. THE COMPLAINT CONDITION IS CONFIRMED FOR CABLE CUTTER AS IT IS MISSING ONE OF THE CARBIDE CUTTING TIPS. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. FURTHER EVALUATION AT THE CHU SHOWS THAT THIS DEVICE IS USED IN THE ORTHOPEDIC CABLE SYSTEM AND THE STERNAL ZIPFIX SYSTEM AND USED FOR CUTTING CABLES AND THE ZIPFIX IMPLANTS. INFORMATION IS PROVIDED IN TECHNIQUE GUIDES. THE RETURNED DEVICE WAS RECEIVED WITH THE CARBIDE INSERT ON THE LEFT JAW SHEARED OFF. THE INSERT WAS NOT RECEIVED. THERE ARE FLATTENING MARKS ON THE DISTAL END OF THE DEVICE. THE BALANCE IS IN GOOD CONDITION. THUS, THE COMPLAINT CONDITION FOR THIS DEVICE IS CONFIRMED BUT CANNOT BE REPLICATED AS THE CARBIDE INSERT IS ALREADY MISSING. A REVIEW OF THE CURRENT DESIGN DRAWING WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE HANDLE OF THE ZIPFIX APPLICATION INSTRUMENT STAYED IN THE CLOSED POSITION DURING A STERNAL CLOSURE PROCEDURE ON (B)(6) 2015. ALSO, IT WAS DISCOVERED THAT ONE OF THE ZIPFIX CABLE CUTTERS WAS MISSING A TIP BLADE WHEN IT CAME OUT OF THE SET. REPLACEMENT DEVICES WERE AVAILABLE FOR USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED SURGICAL DELAY. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411415 CABLE CUTTER-STANDARD CUTTER, WIRE HXZ SYNTHES TUTTLINGEN T990483

    Patients

    Seq Age Sex Outcome Treatment
    1