BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø 3.2X125MM AO FITTING

    MDR report key: 3123731 · Received May 22, 2013

    Report

    Report Number
    0008031020-2013-00161
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE DRILL BIT BROKE COULD BE CONFIRMED. THE VISUAL EXAMINATION REVEALED THAT THE DRILL BIT IS FRACTURED AT THE CUTTING PART. THE FRACTURE SITE SHOWS THE TYPICAL CHARACTERISTICS OF A TORSIONAL OVERLOAD BREAKAGE. WE WERE AWARE THIS DEVICE WAS MANUFACTURED IN 2006 AND THEREFORE WE ASSUME IT WAS MULTIPLE USED. PLEASE NOTE THAT DRILL BITS ARE RECOMMENDED AS SINGLE PATIENT USE ACCORDING THE INSTRUCTIONS FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE OF STRYKER OSTEOSYNTHESIS MEDICAL DEVICES. BASED ON INVESTIGATION, WE CAN ASSUME THE ROOT CAUSE OF THE BREAKAGE WAS MULTI-FACTORIAL. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING OMEGA TWIN HOOK OPERATION, WHILE DRILLING, DRILL BROKE AND TIP OF THE DRILL REMAINED IN THE BONE.

    Description of Event or Problem · 1

    DURING OMEGA TWIN HOOK OPERATION, WHILE DRILLING, DRILL BROKE AND TIP OF THE DRILL REMAINED IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225764 DRILL BIT Ø 3.2X125MM AO FITTING INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH K21232

    Patients

    Seq Age Sex Outcome Treatment
    1 Other