BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE F/

    MDR report key: 21252755 · Received January 28, 2025

    Report

    Report Number
    8030965-2025-00916
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 15, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819020252
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: PHOTO INVESTIGATION: THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION DID NOT REVEAL THAT DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE F/ (315.920) HAD ANY ASSEMBLY OR DISASSEMBLY ISSUE. THE EVIDENCE PROVIDED WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT. FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH PHOTO INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE F/ WOULD NOT CONTRIBUTE TO THE COMPLAINT ABOUT THE DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW (DHR): PART: 315.920, SYNTHES LOT: U375319, SUPPLIER LOT: U375319, RELEASE TO WAREHOUSE DATE: 04 APR, 2021, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR IS DISSATISFIED WITH THE SCREWDRIVER AND THE HOLDING SLEEVE, SINCE THE SHEATH DOES NOT SLIDE COMPLETELY THROUGH THE SCREWDRIVER, WHICH MAKES INSERTION OF THE SCREW DIFFICULT AND OBSTRUCTS THE SURGICAL FIELD, WHICH IS REDUCED IN THE PELVIS. THE SURGERY ENDS SUCCESSFULLY. THE 2.5 DRILL BITS ARE VERY WORN. THE SPECIALIST WAS UPSET AND DECIDED TO BEND 2 DRILL BITS AND REQUESTED THAT NEW DRILL BITS BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550387 DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE F/ DRILL BIT HTW SYNTHES GMBH U375319 07611819020252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female