BEUDAMED
    FDA Adverse Event Other Summary report: N

    NCB-PH TORQUE WRENCH 4 NM

    MDR report key: 2931204 · Received January 22, 2013

    Report

    Report Number
    9613350-2013-01269
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HXC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT YET RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT WAS REPORTED BY THE SURGEON THAT A HARM WAS DONE TO THE PT. HOWEVER THERE IS NO INDICATION FOR A PRODUCT FAILURE AND THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON WAS NOT ABLE TO TIGHTEN DOWN THE LOCKING SCREW WITH THE NCB-PH TORQUE WRENCH 4 NM AFTER MANY TRIALS. IT WAS FURTHER REPORTED THAT THE TORQUE LIMITER HAD OBVIOUSLY RUN IT'S COURSE BUT THERE IS NOTHING TO INDICATE IT NEEDED TO BE REPLACED. IT WAS NOTED BY THE SURGEON THAT THE PT EXPERIENCED HARM AND THE SURGERY WAS EXTENDED FOR 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30428 NCB-PH TORQUE WRENCH 4 NM NCB-PH TORQUE WRENCH 4 NM HXC ZIMMER GMBH 08.345914

    Patients

    Seq Age Sex Outcome Treatment
    1 Other