BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE DIA.4MM SCREWS

    MDR report key: 3003759 · Received February 14, 2013

    Report

    Report Number
    9615741-2013-00004
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    NEWDEAL SAS
    Product Code
    HTJ
    PMA / PMN Number
    K060474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE ALSO USED DURING THIS SURGERY: PRODUCT ID (B)(4) (DEPTH GAUGE FOR DIAMETER 3.5 SCREW) AND PRODUCT ID (B)(4) (STER. TI SCREW AND LOCK SCREW - 3.5MM X 30MM LGT). TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF THREE REPORTS (SAME PATIENT, SAME SURGERY, DIFFERENT PRODUCT IDS, DIFFERENT FAILURE). THIS REPORT IS IN REGARDS TO THE (B)(4) (DEPTH GAUGE DIA. 4MM SCREWS). IT WAS REPORTED THAT THE DEPTH GAUGE APPEARED TO BE INCORRECT. THE SURGEON SAID HE DIDN'T BELIEVE THE DEPTH GAUGES WERE ACCURATE AND HELD THEM AGAINST THE AO DEPTH GAUGE AND ALSO A RULER WHICH SEEMED TO CONFIRM THIS. THE PRODUCT PROBLEM PROBABLY DID ADD TO THE SURGICAL TIME AS HE HAD TO REMOVE TWO SCREWS AS THEY WERE THE WRONG LENGTH AND THEN MEASURED AGAIN USING THE AO DEPTH GAUGE. THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. THERE WAS AN INCREASED OF 60 MINUTES IN SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64571 DEPTH GAUGE DIA.4MM SCREWS NA HTJ NEWDEAL SAS EAGX

    Patients

    Seq Age Sex Outcome Treatment
    1