BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLAT SAW BLADE 1.27MM FAN PWRPRO

    MDR report key: 16368823 · Received February 13, 2023

    Report

    Report Number
    1020279-2023-00313
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    December 20, 2022
    Report Date
    March 6, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRY
    UDI-DI
    03596010515728
    PMA / PMN Number
    K121393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. WITH THE RESULTS OF THIS INVESTIGATION THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY POTENTIAL FACTORS THAT COULD CONTRIBUTE TO 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.

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4). INITIAL MDR REPORT. THE INITIAL REPORTER SENT THE REPORT TO THE FDA UNDER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING SURGERY, THE OSCILLAT SAW BLADE 1.27MM FAN PWRPRO BROKE WHILE USED BY THE SURGEON. ALL PIECES WERE RETRIEVED FROM THE HANDPIECE. A NEW BLADE WAS OPENED AND USED. IT IS UNKNOWN IF THIS CAUSED A SURGICAL DELAY. PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388465 OSCILLAT SAW BLADE 1.27MM FAN PWRPRO PROSTHESIS, KNEE, FEMTIB, SEMI-CONSTRAINED, CEMENTED, MET/POLY HRY SMITH & NEPHEW, INC. 71440365 22BGR1517A 03596010515728

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown