BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RET ROD AMBI/CL WRENCH

    MDR report key: 11688989 · Received April 19, 2021

    Report

    Report Number
    1020279-2021-03201
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    March 23, 2021
    Report Date
    May 21, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KTT
    UDI-DI
    03596010173027
    PMA / PMN Number
    K093047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED RET ROD AMBI/CL WRENCH CONFIRMS THE TIP OF THE DEVICE IS BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED WITH THE DEVICE. THIS DEVICE SHOWS SIGNS OF SIGNIFICANT WEAR AND USE. A MEDICAL INVESTIGATION WAS CONDUCTED AND CONFIRMS THE ROOT CAUSE OF THE REPORTED WRENCH TIP BREAKAGE COULD NOT BE DETERMINED. THE RET ROD AMMBI/CL WRENCHES ARE MANUFACTURED AND INTENDED AS EXTERNALLY COMMUNICATING DEVICES AND ARE NOT APPROVED FOR LONG-TERM INTERNAL TISSUE EXPOSURE AND LONG-TERM IMPLANTATION DATA IS NOT AVAILABLE. SINCE IT WAS REPORTED THAT BROKEN PIECE WAS RETAINED IN THE MATING PART IN THE IMPLANT, THE POSSIBILITY OF MICRO-MOTION AND/OR MIGRATION, AND LOCAL IRRITATION/DISCOMFORT IS UNLIKELY. THE IMPACT TO THE PATIENT BEYOND THAT WHICH HAS BEEN REPORTED CANNOT BE DETERMINED. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. 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. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. 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, DURING A PLANNED REVISION SURGERY FOR REMOVAL OF AN IMPLANT (FROM AN UNKNOWN MANUFACTURER), THE TIP OF A RET ROD AMBI/CL WRENCH BROKE. THE BROKEN PIECE REMAINED INSIDE THE MATING PART OF THE IMPLANT INSIDE THE PATIENT. AT THE END, THE IMPLANT WAS NOT EXPLANTED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583296 RET ROD AMBI/CL WRENCH APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SMITH & NEPHEW, INC. 71110024 UNK 03596010173027

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R