BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INBONE DRILL 6MM STERILE

    MDR report key: 23830183 · Received December 17, 2025

    Report

    Report Number
    3010667733-2025-01533
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 19, 2025
    Report Date
    March 6, 2026
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    GFG
    UDI-DI
    00889797057271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED SINCE THE PROVIDED VIDEO MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, A VIDEO WAS PROVIDED DEMONSTRATING THE STERILE DRILL COULD NOT FULLY ADVANCE THROUGH THE CANNULA WHILE THE NON STERILE DRILL PASSED THROUGH WITHOUT RESISTANCE. QUALITY ASSURANCE ENGINEERING REVIEWED THE AVAILABLE INFORMATION AND NOTED THAT NO UNITS FROM THE REPORTED LOT WERE AVAILABLE FOR EVALUATION. HOWEVER, UNITS FROM A DIFFERENT LOT OF THE STERILE DRILL WERE RETRIEVED FROM INVENTORY FOR ASSESSMENT. KEY DIMENSIONAL MEASUREMENTS WERE PERFORMED AND FOUND TO BE WITHIN PRINT SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "REFERENCE 200134S (THE STERILE VERSION OF THE NON-STERILE BURR 200134 INCLUDED IN THE INSTRUMENT SET) APPEARS TO BE SLIGHTLY OVERSIZED AT THE DISTAL END COMPARED TO THE CANNULA IT SHOULD PASS THROUGH, REFERENCE 200166. THE FIRST BURR IS THE STERILE ONE (REF 200134S), WHICH GETS STUCK IN THE CANNULA, WHILE THE SECOND IS THE NON-STERILE BURR (REF 200134), WHICH SLIDES THROUGH THE CANNULA WITHOUT JAMMING." THIS EVENT WAS IDENTIFIED DURING A PRIMARY SURGERY AND RESULTED IN NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "REFERENCE 200134S (THE STERILE VERSION OF THE NON-STERILE BURR 200134 INCLUDED IN THE INSTRUMENT SET) APPEARS TO BE SLIGHTLY OVERSIZED AT THE DISTAL END COMPARED TO THE CANNULA IT SHOULD PASS THROUGH, REFERENCE 200166. ATTACHED IS AN EXPLANATORY VIDEO: THE FIRST BURR IS THE STERILE ONE (REF 200134S), WHICH GETS STUCK IN THE CANNULA, WHILE THE SECOND IS THE NON-STERILE BURR (REF 200134), WHICH SLIDES THROUGH THE CANNULA WITHOUT JAMMING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304469 INBONE DRILL 6MM STERILE BIT, SURGICAL GFG WRIGHT MEDICAL TECHNOLOGY INC 1815344 00889797057271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown