BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3031047 · Received April 2, 2013

    Report

    Report Number
    3003787298-2013-00041
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE DHR WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD BE RELEVANT TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE MINIATURE BALL AND SPRING ARE MISSING FROM THE RETURNED SLIDER. THE PROXIMAL EDGE OF THE HOLE THAT RETAINS THE BALL AND SPRING IS DAMAGED AND APPROXIMATELY HALF OF THE EDGE HAS BROKEN OFF. AS DESIGNED, THE BALL AND SPRING ARE STAKED IN PLACE ON THE SLIDER AND THE HOLE ON THE RETURNED PART HAS MARKS INDICATING THAT THE PARTS WERE STAKED WHEN IT WAS PRODUCED. THE BALL AND SPRING WERE NOT RETURNED. THE DEPTH GAUGE CAN STILL BE USED IN ITS CURRENT STATE BUT TAKES A LITTLE MORE EFFORT TO HOLD THE SLEEVE AND SLIDER TO READ THE MEASUREMENT. THE DEPTH GAUGE IS DESIGNED TO COME APART AND THE BALL AND SPRING ARE INTENDED TO PREVENT THE DEPTH GAUGE FROM COMING APART TOO EASILY AND TO HOLD IT WHEN THE USER IS MEASURING FOR SCREW LENGTH. IF THE BALL AND SPRING ARE MISSING, THE DEPTH GAUGE CAN STILL BE USED TO MEASURE THE SCREW LENGTH BUT THE ASSEMBLY WILL COME APART EASILY. AS DESIGNED, THE BALL AND SPRING ARE LOCATED IN THE SLIDER ASSEMBLY AND STAKED IN PLACE. THE STAKE MARKS ARE PRESENT ON THE HOLE OF THE RETURNED PART INDICATING THAT IT WAS ASSEMBLED PROPERLY WHEN MANUFACTURED. THE LOWER EDGE OF THE HOLE IS DINGED AND PART OF THE EDGE OF THE HOLE HAS BEEN BROKEN OFF WHICH WOULD COMPROMISE RETENTION OF THE BALL AND SPRING. THE RETURNED DEVICE WAS PRODUCED IN NOVEMBER 2010 AND IS OVER 2 YEARS OLD. THE TFN-TROCHANTERIC FIXATION NAIL RISK ANALYSIS ADEQUATELY ASSESSES THE RISK ASSOCIATED WITH THIS COMPLAINT CONDITION OF INSTRUMENT BREAKAGE DUE TO INAPPROPRIATE DIMENSIONS AS LESS SEVERE WITH A MODERATE SEVERITY OF HARM 3 AND AN UNLIKELY PROBABILITY OF OCCURRENCE 2. THE RISK ANALYSIS ALSO ADEQUATELY ASSESSES THE RISK ASSOCIATED WITH THIS COMPLAINT CONDITION OF INSTRUMENT BREAKAGE DUE TO WRONG MATERIAL SPECIFIED AS LESS SEVERE WITH A MODERATE SEVERITY OF HARM 3 AND AN IMPROBABLE PROBABILITY OF OCCURRENCE 1. ALSO, SINCE THE DEVICE CAN STILL BE USED WITHOUT THE BALL AND SPRING PRESENT, THE RISK OF THE COMPLAINT CONDITION IS MINIMAL. THE DESIGN IS ACCEPTABLE FOR THE INTENDED USE.

    Description of Event or Problem · 1

    THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6), 2013, DURING A TROCHANTERIC FIXATION NAIL PLACEMENT PROCEDURE, THE METAL BALL STOP ON THE DEPTH GAUGE WAS NOTICED TO BE MISSING. NO ALTERNATE WAS AVAILABLE, BUT SINCE IT WAS A SHORT NAIL PLACEMENT IT WAS NOT REQUIRED FOR THE PROCEDURE. THE DEPTH GAUGE WITH THE MISSING BALL STOP REMAINS IN THE TFN LOCKING SET. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135118 LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS HTJ SYNTHES JENNERSVILLE 6518180

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization