BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT SCREWDRIVER

    MDR report key: 10469243 · Received August 28, 2020

    Report

    Report Number
    1020279-2020-04286
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    August 4, 2020
    Report Date
    September 6, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LRZ
    UDI-DI
    03596010454188
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION A VISUAL INSPECTION CONFIRMS THE STRAIGHT SCREWDRIVER IS STRIPPED AND ROUNDED OFF ON BOTH ENDS OF THE DEVICE. THE DEVICE SHOWS EXTENSIVE SIGNS OF WEAR/USAGE. THE DEVICE WAS MANUFACTURED IN 2009. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PART REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCH WITH THE SAME FAILURE MODE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES; DAMAGE FROM REPEATED USE CAN OCCUR. EXPECTED WEAR/TEAR IS LIKELY THE PROBABLE CAUSE OF THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINTS WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THESE COMPLAINTS; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END OF DRIVER WAS FOUND ROUNDED DURING SET UP OR INSPECTION. NO DELAY OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933717 STRAIGHT SCREWDRIVER SCREWDRIVER, SURGICAL LRZ SMITH & NEPHEW, INC. 71362293 09DM06909 03596010454188

    Patients

    Seq Age Sex Outcome Treatment
    1