BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE-READY CERCLAGE CABLES

    MDR report key: 6967311 · Received October 20, 2017

    Report

    Report Number
    0001822565-2017-07261
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 21, 2017
    Report Date
    May 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KTT
    PMA / PMN Number
    PK151907
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION CONFIRMED THE FRACTURE OF THE CABLE. THE CABLE WAS CRIMPED IN TWO AREAS AND FRACTURED IN TWO AREAS. THE CAP SCREW WAS FRACTURED AND RETURNED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS: 00-8114-002-18, CPT 12/14 SIZE 2 COCR 180MM STD, LOT: 63008940. 00-8011-010-01, 12MM/16MM PLUGS WITH INSERTER, LOT: 63316659. 00-8018-028-03, VERSYS FEMORAL HEAD + 3.5 X 28, LOT: 63458694. 00-5001-049-00, BIPOLAR METAL SHELL 49 OD, LOT: 63544507. 00-5001-047-28, LINER ASSY 47/48/49 OD X 28 ID, LOT: 63630956. 00-2232-002-05, INTEGRAL LONG GTR W/ 4 CABLES, LOT: 56654807. 00-2232-004-18, 1.8 CABLE ASSY COCR 25, LOT: 63732478. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER TENSIONING THE CABLE AND LOCKING THE SCREW, THE SCREW HEAD FRACTURED. THE CABLE WAS CUT AND REMOVED, AND THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. NO SERIOUS INJURY WAS REPORTED, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CERLAGE WIRE FRACTURED UNDER TENSIONING. AFTER A 15 MINUTE DELAY, THE CABLE WAS DISCARDED AND THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745201 CABLE-READY CERCLAGE CABLES CERCLAGE, FIXATION KTT ZIMMER BIOMET, INC. N/A 63650819

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention