BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING

    MDR report key: 3951690 · Received July 23, 2014

    Report

    Report Number
    0008010177-2014-00186
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT THAT 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING WAS ALLEGED OF ISSUE S-11 (BREAKAGE DURING SURGERY) COULD BE CONFIRMED. THE ROOT CAUSE OF THIS BREAKAGE ISSUE HAS BEEN IDENTIFIED AS A DESIGN ISSUE. THIS PROBLEM HAS BEEN REPORTED THROUGH NC 936139 AND IS NOW ADDRESSED BY CAPA (B)(4). THE DEVICE INSPECTION REVEALED THE FOLLOWING: TIP BREAKAGE WAS VERIFIED. GIVEN THE NATURE OF THE RETURNED DEVICE, A DIMENSIONAL INSPECTION COULD NOT BE PERFORMED. GIVEN THE NATURE OF THE RETURNED DEVICE, A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    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 THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF THE DRIVER WAS BROKEN. ACCORDING TO THE SR, THE DRIVER WAS BROKEN DURING SURGERY, BUT THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF THE DRIVER WAS BROKEN. ACCORDING TO THE SR, THE DRIVER WAS BROKEN DURING SURGERY, BUT THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430221 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER LEIBINGER FREIBURG AC04

    Patients

    Seq Age Sex Outcome Treatment
    1 Other