BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FGT IMPACTOR

    MDR report key: 24285998 · Received February 7, 2026

    Report

    Report Number
    3002788818-2026-00017
    Event Type
    Malfunction
    Date Received
    February 7, 2026
    Date of Event
    January 19, 2026
    Report Date
    March 10, 2026
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    HWA
    UDI-DI
    00885556834480
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN RISKS WITH THE DEVICE ITSELF OR WITH ITS USE THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). ADDITIONAL INFORMATION: D9: IS THIS DEVICE AVAILABLE FOR EVALUATION? H6: COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H11: THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION REVEALED THE TYPE 5 GROOVE PIN FRACTURED AND THE GROMMET IMPACTOR HEAD FRACTURED OFF AND NOT RETURNED. THE RETURNED PORTION OF THE DEVICE ARE WORN FROM USE. DEVICE BATCH NUMBER WAS NOT PROVIDED; THUS, AN EVALUATION OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. A REVIEW OF COMPLAINT HISTORY FOR THE PREVIOUS 12 MONTHS 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 EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY 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 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 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 · 0

    IT WAS REPORTED THAT, DURING AN MTP ARTHRODESIS, THE HEAD OF ONE (1) FGT IMPACTOR BROKE APART UPON IMPACTING. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. THERE WAS A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560757 FGT IMPACTOR IMPACTOR HWA ASCENSION ORTHOPEDICS, INC. UNKNOWN 00885556834480

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown