BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIUM HEXDRIVER

    MDR report key: 10535420 · Received September 15, 2020

    Report

    Report Number
    1020279-2020-04575
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    August 15, 2020
    Report Date
    July 29, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSB
    UDI-DI
    03596010478443
    PMA / PMN Number
    K122170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE ASSOCIATED DEVICE, USED IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE TIP OF THE SLEEVE ON THE DEVICE IS BROKEN, RENDERING THE DEVICE INOPERATIVE. THE DEVICE SHOWS SIGNS OF EXTENSIVE USE. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT THE FIVE ARTHROSCOPIC IMAGES, A SINGLE PHOTO AND PRODUCT EVALUATION ALL CONFIRM THE REPORTED FAILURE. BASED ON THE FINDINGS OF THE PRODUCT EVALUATIONS, AGE RELATED WEAR WAS THE LIKELY CAUSE OF THE REPORTED FAILURE. ALTHOUGH, WE CANNOT RULE OUT EXCESSIVE TORQUE AS A CONTRIBUTING FACTOR. PER COMMUNICATIONS, THE TIP WAS REMOVED WITH KELLY FORCEPS AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT DELAY. THE IMPACT TO THE PATIENT AND WHAT WAS REPORTED AS ¿BURNED IN THE PATIENT¿S ARTICULATION¿, CANNOT BE CONCLUDED AS IT¿S NOT UNDERSTOOD WHAT IS MEANT BY THIS STATEMENT AND IF IT¿S MEANT TO BE ¿BURIED¿ IN THE PATIENT¿S ARTICULATION. THE STATUS OF THE PATIENT AND THE TREATMENT IS UNKNOWN. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-ASSESSED. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS AND ASSESSED FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE DO NOT HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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 PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY PROBABLE CAUSES OF THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION BUT THE PICTURES WERE REVIEWED, AND THE FAILURE MODE WAS CONFIRMED, THE TIP OF THE HEXDRIVER WAS BROKEN. THE CLINICAL / MEDICAL INVESTIGATION CONCLUDED THAT, THE FIVE ARTHROSCOPIC IMAGES AND A SINGLE PHOTO PROVIDED ALL CONFIRM THE REPORTED FAILURE. PER SUBSEQUENT EMAIL, NO FURTHER CLINICAL INFORMATION, NOR THE DEVICE BE RETURNED, THEREFORE, ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. HOWEVER, WE CANNOT RULE OUT EXCESSIVE TORQUE AS THE LIKELY CAUSE. PER COMMUNICATIONS, THE TIP WAS REMOVED WITH KELLY FORCEPS AND THE PROCEDURE COMPLETED WITH THE SAME DEVICE WITHOUT DELAY. THE IMPACT TO THE PATIENT AND WHAT WAS REPORTED AS ¿BURNED IN THE PATIENT¿S ARTICULATION¿, CANNOT BE CONCLUDED AS IT¿S NOT UNDERSTOOD WHAT IS MEANT BY THIS STATEMENT AND IF IT¿S MEANT TO BE ¿BURIED¿ IN THE PATIENT¿S ARTICULATION. THE STATUS OF THE PATIENT AND THE TREATMENT IS UNKNOWN. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WOULD BE RE-ASSESSED. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH FOR 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. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY PROBABLE CAUSES OF THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; 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 SURGERY IN THE PLUG PLACEMENT WHEN ENTERED THE MEDIUM HEXDRIVER THE SCREW WAS POSITIONING TOO STRONG AND THE TIP OF THE MEDIUM HEXDRIVER BROKE. IT BURNED IN THE PATIENT'S ARTICULATION AND WAS REMOVED WITH KELLY FORCEPS. NO DELAY WAS REPORTED. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000461 MEDIUM HEXDRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SMITH & NEPHEW, INC. 71631066 03DM04040 03596010478443

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention