BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULLUP INSTRUMENTATION

    MDR report key: 22182393 · Received June 11, 2025

    Report

    Report Number
    3004549189-2025-00010
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 27, 2025
    Report Date
    February 9, 2026
    Manufacturer
    S.B.M. SAS
    Product Code
    HTW
    UDI-DI
    03760154006163
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2025. NOT ENOUGH ELEMENTS: INVESTIGATION IS ONGOING AND RESULTS ARE NOT YET AVAILABLE. WAITING FURTHER INFORMATION ON THE POTENTIAL CONSEQUENCES FOR THE PATIENT AND THE CIRCUMSTANCES OF THE INCIDENT. RECURRING INCIDENT WITH THE SAME SURGEON: INVESTIGATION IN PROGRESS / EXCHANGES PLANNED BETWEEN HIM AND OUR SALES AND TECHNICAL DEPARTMENTS. (B)(6) 2026. FOLLOW UP1 - RESULT OF EXPERTISE. DEVICE HISTORY RECORD REVIEW: THE DRILL BIT MATERIAL COMPLIES WITH: 1.4543 / X3CRNICUTINB12-9 ACCORDING TO STANDARD NF S 94-090. COMPLIANT SHARPENING DIMENSIONS - COMPLIANT OUTER DIAMETER. COMPLIANT H900 HEAT TREATMENT / HARDNESS: 47 HRC ON THE HEAT TREATMENT CERTIFICATE (SPECIFICATION: GREATER THAN OR EQUAL TO 47HRC). EXTERNAL EXPERTISE/DIFFERENT RESULT: 51.6 HRC AT THE CORE AND 51.8 HRC ON THE SURFACE. COMPLIANT LASER MARKING - COMPLIANT PASSIVATION TREATMENT. TESTS / ADDITIONAL ANALYSES: MATERIAL HARDNESS TESTING IN AN INDEPENDENT LABORATORY. A) CHECKING THE MINIMUM THICKNESS AT THE BOTTOM OF THE GROOVE AFTER CUTTING WITH A DRILL BIT FROM THE SAME BATCH / RESULT COMPLIES. B) BREAKAGE REPRODUCTION TEST: NO EFFECT REGARDLESS OF THE MATERIAL BEING DRILLED, EVEN WHEN TWISTING THE SPINDLE AND WITH THE DRILL BIT ROTATING. THE DRILL BIT IS NOT DAMAGED, WITH NO CHIPPING OR BREAKAGE OF THE FLUTES. 1. ON A Ø4.5MM DRILL BIT FROM THE SAME LOT 242529 (SAME MATERIAL SUPPLIER AS THE LOT CONCERNED). RESULT: ONLY ONE CHIPPED TOOTH, WITH THE TIP OF A PAIR OF NEEDLE-NOSE PLIERS INSERTED INTO THE CANNULA, AND THE SIDE OF THE TIP INTERFERING BEFORE THE MOTOR STARTED. 2. ON A DRILL BIT FROM LOT 242531 (FROM A DIFFERENT MATERIAL SUPPLIER). RESULT: SLIGHTLY BLUNT CUTTING EDGE, USING THE SAME METHODOLOGY AS IN POINT 1). C) HARDNESS MEASUREMENT: 537±33 HV = 51.6 HRC AT THE CORE AND 548±33 HV = 51.8 HRC ON THE SURFACE INSTEAD OF 47HRC AS STIPULATED ON THE HEAT TREATMENT CERTIFICATE. THE MANUFACTURE OF THE DRILL BITS IS NOT CONSIDERED TO BE THE CAUSE OF THE FAILURE. PRODUCT OBSERVATION: THE BASE OF A GROOVE HAS A PERMANENT CREASE, THE RESULT OF STRESS EXCEEDING THE ELASTIC LIMIT OF MX455 MATERIAL. THE CUTTING EDGES APPEAR INTACT, AND THE BREAKAGE AREAS ARE CLEAN. ALL THE BREAK LINES ORIGINATE IN THE HOLLOW OF THE LOBES, THE AREA WHERE THE MATERIAL IS THINNEST THERE ARE SLIGHT TRACES OF OXIDATION IN THE CANNULATED HOLE, BUT NOT IN THE FRACTURE AREAS, AND NO TRACES OF "OLD" PRIMERS. ROOT CAUSE / HYPOTHESIS: IN VIEW OF THE RESULTS OF TESTS CONDUCTED TO REPRODUCE THE FAILURE OF THE Ø4.5MM CANNULATED DRILL BIT AND THE DESCRIPTION OF THE CONDITIONS UNDER WHICH THE BREAKAGE OCCURRED AS REPORTED BY THE SURGEON, THE BREAKAGE OF THE DRILL BIT APPEARS TO HAVE BEEN CAUSED BY SIGNIFICANT STRESS APPLIED TO THE TIP OF THE DRILL BIT AT THE START OF DRILLING. MORE SPECIFICALLY, IT WAS CAUSED BY THE APPLICATION OF SIGNIFICANT TORQUE TO THE TIP OF THE DRILL BIT IN CONTACT WITH THE BONE VIA THE SURGICAL MOTOR, COMBINED WITH BENDING STRESSES VIA THE GUIDE PIN AND THE MOTOR, DUE TO THE LATTER BEING MISALIGNED WITH THE AXIS OF THE TUNNEL. AS A PRECAUTIONARY MEASURE, REPLACE CANNULATED DRILL BITS REF. (B)(4) WITH Ø4.5 CANNULATED DRILL BITS REF. (B)(4) FROM ANOTHER BRAND/SUPPLIER, PREVIOUSLY USED BY THE SURGEON. NO OTHER INCIDENTS.

    Additional Manufacturer Narrative · 0

    ON 11 JUNE 2025 NOT ENOUGH ELEMENTS: INVESTIGATION IS ONGOING AND RESULTS ARE NOT YET AVAILABLE. WAITING FURTHER INFORMATION ON THE POTENTIAL CONSEQUENCES FOR THE PATIENT AND THE CIRCUMSTANCES OF THE INCIDENT. RECURRING INCIDENT WITH THE SAME SURGEON: INVESTIGATION IN PROGRESS / EXCHANGES PLANNED BETWEEN HIM AND OUR SALES AND TECHNICAL DEPARTMENTS.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN FRANCE. EVENT DESCRIPTION COMMUNICATED. "A 4.5MM DRILL BIT BROKE AGAIN ON TUESDAY IN THE (B)(6) CLINIC'S OPERATING ROOM".

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN FRANCE. EVENT DESCRIPTION COMMUNICATED. "A 4.5MM DRILL BIT BROKE AGAIN ON TUESDAY IN THE (B)(6) OPERATING ROOM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96270 PULLUP INSTRUMENTATION Ø 4.5MM CANNULATED DRILL BIT HTW S.B.M. SAS 242529 03760154006163

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other