BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T25 SELF-RET SCREWDRIVER W/QC 178MM

    MDR report key: 13591603 · Received February 24, 2022

    Report

    Report Number
    1020279-2022-00850
    Event Type
    Injury
    Date Received
    February 24, 2022
    Date of Event
    February 4, 2022
    Report Date
    April 6, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HXX
    UDI-DI
    03596010637178
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEVICE WAS FOUND TO BE FRACTURED ALONG THE TIP, RENDERING THE DEVICE INOPERATIVE. THE DEVICE SHOWS SIGNS OF EXTENSIVE USE. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. THE CLINICAL/MEDICAL EVALUATION CONCLUDED THAT BASED ON THE INFORMATION PROVIDED, THE BROKEN TIP OF A T25 SELF RET SCREWDRIVER W/QC 178MM WAS REMOVED FROM INSIDE OF THE PATIENT. THE TWO UNDATED, UNLABELED PHOTOS OF THE DEVICE PROVIDED SUPPORTS THE COMPLAINT. ACCORDING TO THE REPORT, THE SURGEON COMPLETED THE PROCEDURE WITHOUT DELAY, USING A SMITH & NEPHEW BACK UP DEVICE. SINCE THERE WAS NO ALLEGED HARM TO THIS PATIENT, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL RELEVANT PATIENT INFORMATION BE PROVIDED, THIS CASE WOULD BE RE-ASSESSED. 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. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. ASSESSMENT OF HISTORICAL ESCALATED CASES CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS DEVICE AND FAILURE MODE. A CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD BE CORROBORATED AS THE DEVICE SHOWS SIGNS OF DAMAGE/WEAR. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE 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 FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED. B5

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE TIP OF A T25 SELF-RET SCREWDRIVER W/QC 178 MM BROKE OFF INSIDE THE PATIENT. ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE TIP OF A T25 SELF-RET SCREWDRIVER W/QC 178 MM BROKE OFF INSIDE THE PATIENT. ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE TIP OF A T25 SELF-RET SCREWDRIVER W/QC 178MM BROKE OFF INSIDE THE PATIENT. ALL PIECES WERE RECOVERED BY HAND. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129461 T25 SELF-RET SCREWDRIVER W/QC 178MM SCREWDRIVER HXX SMITH & NEPHEW, INC. 71173616 13KBG0009 03596010637178

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other