BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE 1/4SQNONRTCHT TL90

    MDR report key: 5741284 · Received June 22, 2016

    Report

    Report Number
    0002184052-2016-00098
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Date of Event
    May 24, 2016
    Report Date
    April 26, 2017
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK132884
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. SUPPLEMENTAL REPORT FOUR OF FOUR FOR THE SAME EVENT; SEE ALSO 0002184052-2016-00095-1, 00096-1 AND 00097-1.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT FOUR OF FOUR FOR THE SAME EVENT; SEE ALSO 0002184052-2016-00095, 00096 AND 00097.

    Additional Manufacturer Narrative · 1

    THE EVENT INVOLVING THIS DEVICE WAS INITIALLY INCORRECTLY ASSESSED. NO PATIENT/USER INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. THE RETURNED TORQUE HANDLE WAS MECHANICALLY TESTED. IT LIMITED THE TORQUE AS EXPECTED; HOWEVER, THE OUTPUT WAS WITHIN TO BELOW THE LOWEST MINIMUM REQUIREMENT. HOWEVER THIS WOULD BE UNLIKELY TO IMPACT THE CROSS-THREADING OF THE CLOSURE TOP. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED THAT THE INSTRUMENT WOULD NOT ASSEMBLE WITH MATING INSTRUMENT. WHEN TIGHTENING THE NUT WITH THE TORQUE HANDLE ON S1 RIGHT, THERE WAS A STRANGE NOISE. THE SURGEON STATED IT FELT AS IF THE SCREW HEAD WAS DESTROYED. HOWEVER, IT WAS THE THREAD OF THE NUT WHICH HAD BEEN PEELED. ACCORDING TO THE SURGEON THERE WAS NO CROSS THREADING, BECAUSE THE SCREW WAS ANCHORED CORRECTLY TO THE EXTENDER. THE SCREW WAS INSERTED TO THE "SCREW ASSEMBLY TOOL" IN THE SHORT EXTENDER BY THE NURSE. THE NUT ROTATED EASILY THROUGH THE 3CM REDUCTION SCREW EXTENDER. ALL FRAGMENTS WERE REMOVED AND THE NUT WAS SCREWED BACK INTO THE EXTENDER. THE EXTENDER WAS REMOVED TOGETHER WITH THE PINNING NUT. THE SCREW WAS INTACT AND WAS LEFT IN THE PATIENT. A NEW NUT WAS APPLIED WITHOUT EXTENDER. EXTENDER, NUT AND TORQUE HANDLE WILL BE RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE SURGERY WAS COMPLETED AND IT WAS NOT A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397121 T-HANDLE 1/4SQNONRTCHT TL90 MODULAR T-HANDLE NKB ZIMMER SPINE N/A 77BQ-017

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R