BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULLUP INSTRUMENTATION

    MDR report key: 20417439 · Received October 10, 2024

    Report

    Report Number
    3004549189-2024-00008
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 19, 2024
    Report Date
    November 5, 2024
    Manufacturer
    S.B.M. SAS
    Product Code
    HTW
    UDI-DI
    03760154006163
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    10 OCTOBER 2024. ADDITIONAL INFORMATIONS REQUESTED: DATE OF INCIDENT: NAME AND ADDRESS OF HEALTH CARE FACILITY: NAME OF SURGEON: CLINICAL CONSEQUENCES FOR THE PATIENT: WHEN EXACTLY DID THIS BREAK HAPPEN? PLEASE REPORT ON THE CIRCUMSTANCE WHEN THE EVENT OCCURRED: HAS THE PATIENT RETAINED A PIECE OF BROKEN DEVICE? ARE THERE ANY CONTRIBUTING FACTORS RELATED TO THE EVENT? IF YES, COULD YOU EXPLAIN? WAS THE DURATION OF SURGERY EXTENDED BY MORE THAN 30 MINUTES AS A RESULT OF THE EVENT? WHAT ARE REMEDIAL ACTIONS TAKEN BY HEALTH CARE FACILITY SUBSEQUENT TO THE INCIDENT? IS THE SURGEON USED TO USING THIS INSTRUMENT? IS IT POSSIBLE TO RETURN THE DEFECTIVE PRODUCT TO MY ATTENTION? DID THE HEALTH CARE FACILITY DECLARE THIS INCIDENT TO THE NATIONAL COMPETENT AUTHORITY? ACCORDING WITH CURRENT LEGISLATION OF YOUR COUNTRY, IS THIS TYPE OF EVENT SHOULD BE REPORTED TO YOUR NATIONAL COMPETENT AUTHORITY? INCIDENT DETAILS RETRIEVED ON 08 OCTOBER 2024. PATIENT INFORMATION: "THE SURGICAL TEAM DID NOT REALIZE THAT PART OF THE DRILL BIT HAD BROKEN OFF ON THE TIP. THE DOCTOR JUST DISCOVERED THE PRESENCE OF METAL FRAGMENTS IN THE FEMUR AFTER AN X-RAY WAS PERFORMED ON THE PATIENT. THE DOCTOR DID NOT VISUALLY NOTICE IT ON THE ARTHROSCOPY SCREEN WHEN INSERTING THE GRAFT". "THE METAL FRAGMENTS REMAIN IN THE PATIENT'S LEG, INSIDE THE FEMORAL TUNNEL, AND COVERED BY THE GRAFT - THE DOCTOR ONLY INFORMED TO TAKE NOTES AND CONDUCT A GRADUAL EVALUATION OF THE PATIENT". NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER OR THIS TYPE OF INCIDENT. VERIFICATION OF MANUFACTURING DATA: THE RESULTS OF CHECKS CARRIED OUT COMPLY WITH EXPECTED SPECIFICATIONS. AWAITING RECOVERY OF DRILL BIT FOR ANALYSIS.

    Additional Manufacturer Narrative · 0

    ON 10 OCTOBER 2024: ADDITIONAL INFORMATIONS REQUESTED: DATE OF INCIDENT: NAME AND ADDRESS OF HEALTH CARE FACILITY: NAME OF SURGEON: CLINICAL CONSEQUENCES FOR THE PATIENT: WHEN EXACTLY DID THIS BREAK HAPPEN? PLEASE REPORT ON THE CIRCUMSTANCE WHEN THE EVENT OCCURRED: HAS THE PATIENT RETAINED A PIECE OF BROKEN DEVICE? ARE THERE ANY CONTRIBUTING FACTORS RELATED TO THE EVENT? IF YES, COULD YOU EXPLAIN? WAS THE DURATION OF SURGERY EXTENDED BY MORE THAN 30 MINUTES AS A RESULT OF THE EVENT? WHAT ARE REMEDIAL ACTIONS TAKEN BY HEALTH CARE FACILITY SUBSEQUENT TO THE INCIDENT? IS THE SURGEON USED TO USING THIS INSTRUMENT? IS IT POSSIBLE TO RETURN THE DEFECTIVE PRODUCT TO MY ATTENTION? DID THE HEALTH CARE FACILITY DECLARE THIS INCIDENT TO THE NATIONAL COMPETENT AUTHORITY? ACCORDING WITH CURRENT LEGISLATION OF YOUR COUNTRY, IS THIS TYPE OF EVENT SHOULD BE REPORTED TO YOUR NATIONAL COMPETENT AUTHORITY? INCIDENT DETAILS RETRIEVED ON 08 OCTOBER 2024. PATIENT INFORMATION: "THE SURGICAL TEAM DID NOT REALIZE THAT PART OF THE DRILL BIT HAD BROKEN OFF ON THE TIP. THE DOCTOR JUST DISCOVERED THE PRESENCE OF METAL FRAGMENTS IN THE FEMUR AFTER AN X-RAY WAS PERFORMED ON THE PATIENT. THE DOCTOR DID NOT VISUALLY NOTICE IT ON THE ARTHROSCOPY SCREEN WHEN INSERTING THE GRAFT". "THE METAL FRAGMENTS REMAIN IN THE PATIENT'S LEG, INSIDE THE FEMORAL TUNNEL, AND COVERED BY THE GRAFT - THE DOCTOR ONLY INFORMED TO TAKE NOTES AND CONDUCT A GRADUAL EVALUATION OF THE PATIENT". NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER OR THIS TYPE OF INCIDENT. VERIFICATION OF MANUFACTURING DATA: THE RESULTS OF CHECKS CARRIED OUT COMPLY WITH EXPECTED SPECIFICATIONS. AWAITING RECOVERY OF DRILL BIT FOR ANALYSIS. 05 NOVEMBER 2024 - FOLLOW UP1 - RÉSULT OF EXPERTISE: ADDITIONAL INFORMATION: NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER OR THIS TYPE OF INCIDENT - VERIFICATION OF MANUFACTURING DATA: THE RESULTS OF CHECKS CARRIED OUT COMPLY WITH EXPECTED SPECIFICATIONS. A QUARTER OF THE CUTTING PART IS MISSING, THE BREAK STARTS AT THE BOTTOM OF THE FLUTE AND RUNS UP ALONG THE THINNEST PART. ALL THE EDGES OF THE CUTTING PART ARE BLUNT. WE CAN NOTE A BLUISH COLORATION AT THE TIP OF THE DRILL, A SIGN THAT THERE WAS A SLIPPAGE AND VERY HIGH HEATING. A SECOND INCIPIENT BREAK APPEARS AT 180° FROM THE MISSING PART. THE MINIMUM THICKNESS OF THE LINER AT THE BOTTOM OF THE FLUTE IS SLIGHTLY GREATER THAN 0.39MM, MAXIMUM DIMENSION REQUIRED DURING MANUFACTURING. THE IMPRECISION OF THIS MEASUREMENT, DUE TO THE DEFORMATION OF THE AREA, SUGGESTS THAT THE MINIMUM THICKNESS REQUIRED WAS INDEED EFFECTIVE. THE DRILL BIT SHOWS ABNORMAL WEAR, IT SHOULD HAVE BEEN DISCARDED BEFORE THE INTERVENTION, AT THE FIRST SIGNS OF DIFFICULTY IN DRILLING. HYPOTHESIS NO. 1: BREAKAGE DUE TO IMPACT, WHEN ONE OF THE CUTTING EDGES ENCOUNTERS A STAINLESS STEEL PIN, A SHAVER OR OTHER SIGHT. HYPOTHESIS NO. 2: DRILL BIT DULLED AND SHATTERED DURING A PREVIOUS INTERVENTION, HIGH CUTTING EFFORT DURING THIS DRILLING, AND BREAKAGE OF A LOBE. "THE SURGICAL TEAM DID NOT REALIZE THAT PART OF THE DRILL BIT HAD BROKEN OFF ON THE TIP. THE DOCTOR JUST DISCOVERED THE PRESENCE OF METAL FRAGMENTS IN THE FEMUR AFTER AN X-RAY WAS PERFORMED ON THE PATIENT. THE DOCTOR DID NOT VISUALLY NOTICE IT ON THE ARTHROSCOPY SCREEN WHEN INSERTING THE GRAFT". THE DOCTOR ONLY INFORMED TO TAKE NOTES AND CONDUCT A GRADUAL EVALUATION OF THE PATIENT. EXPERTISE RESULT SENT TO DISTRIBUTOR ON NOVEMBER 04, 2024 - FOLLOW-UP BY OUR SALES DEPARTMENT.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN MALAISIA. EVENT DESCRIPTION COMMUNICATED. "WE WOULD LIKE TO INFORM THAT OUR ORDER FOR ITEM CANNULATED DRILL BIT Ø 4.5 MM (PULL000255) IS BECAUSE THE ITEM IS BROKEN FROM THE POST SURGERY ACL RECON PROCEDURE. THE ITEM THAT WAS USED AT THAT TIME IS PULL000255, WITH LOT NUMBER 221735. PLEASE FIND ATTACHED THE ITEM PHOTOS FOR REFERENCE. THIS ITEM IS ALSO FREQUENTLY USED AND VERY NEEDED ON THE ACL/PCL RECONSTRUCTION PROCEDURE".

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN INDONESIA. EVENT DESCRIPTION COMMUNICATED. "WE WOULD LIKE TO INFORM THAT OUR ORDER FOR ITEM CANNULATED DRILL BIT Ø 4.5 MM (PULL000255) IS BECAUSE THE ITEM IS BROKEN FROM THE POST SURGERY ACL RECON PROCEDURE. THE ITEM THAT WAS USED AT THAT TIME IS PULL000255, WITH LOT NUMBER 221735. PLEASE FIND ATTACHED THE ITEM PHOTOS FOR REFERENCE. THIS ITEM IS ALSO FREQUENTLY USED AND VERY NEEDED ON THE ACL/PCL RECONSTRUCTION PROCEDURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933233 PULLUP INSTRUMENTATION Ø 4.5 MM CANNULATED DRILL BIT HTW S.B.M. SAS 221735 03760154006163

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other