BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH

    MDR report key: 9534980 · Received December 31, 2019

    Report

    Report Number
    0001822565-2019-05494
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 13, 2019
    Report Date
    June 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KTT
    PMA / PMN Number
    K151907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H10 . VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE CABLES ARE FRAYED AND FRACTURED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 · 0

    13 LOT NUMBERS WERE RECEIVED FOR THIS COMPLAINT. IT IS UNKNOWN WHICH 7 OF THE 13 LOT NUMBERS MALFUNCTIONED. PLEASE SEE THE BELOW PRODUCT INFORMATION: CAT: 22320418 LOT: 64297449 QTY 1 EXP DATE: 31 JAN 2029 UDI: (B)(4) CAT: 22320418 LOT: 64245448 QTY 1 EXP DATE: 30 NOV 2028 UDI: (B)(4) CAT: 22320418 LOT: 64297408 QTY 1 EXP DATE: 31 JAN 2029 UDI: (B)(4) CAT: 22320418 LOT: 64230631 QTY 1 EXP DATE: 30 NOV 2028 UDI: (B)(4) CAT: 22320418 LOT: 63759966 QTY 1 EXP DATE: 31 AUG 2027 UDI: (B)(4) CAT: 22320418 LOT: 64479177 QTY 1 EXP DATE: 31 JUL 2029 UDI: (B)(4) CAT: 22320418 LOT: 64123313 QTY 1 EXP DATE: 31 JUL 2028 UDI: (B)(4) CAT: 22320418 LOT: 64536598 QTY 1 EXP DATE: 30 SEP 2029 UDI: (B)(4) CAT: 22320418 LOT: 64500356 QTY 2 EXP DATE: 31 AUG 2029 UDI: (B)(4) CAT: 22320418 LOT: 64523103 QTY 3 EXP DATE: 30 SEP 2029 UDI: (B)(4). 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CABLE CERCLAGE CABLE, CAT#:00223200418, LOT#:NI. CABLE CERCLAGE CABLE, CAT#:00223200418, LOT#:NI. CABLE CERCLAGE CABLE, CAT#:00223200418, LOT#:NI. CABLE CERCLAGE CABLE, CAT#:00223200418, LOT#:NI. CABLE CERCLAGE CABLE, CAT#:00223200418, LOT#:NI. CABLE CERCLAGE CABLE, CAT#:00223200418, LOT#:NI. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 05488, 0001822565 - 2019 - 05489, 0001822565 - 2019 - 05490, 0001822565 - 2019 - 05491, 0001822565 - 2019 - 05492, 0001822565 - 2019 - 05493.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CABLES WERE TENSIONED SOME STRANDS BROKE AND THE CABLES NEEDED TO BE CUT TO GET THE TENSIONING CLAMP OFF. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329488 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10.