BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEPPED, RATCHET DRILL SLEEVE

    MDR report key: 5953209 · Received September 15, 2016

    Report

    Report Number
    1220246-2016-00384
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    August 17, 2016
    Report Date
    September 30, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867196766
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. NO DEVICE MALFUNCTION IDENTIFIED IN ACCORDANCE WITH 21CFR 803.3, SECTION 2.14. AT THIS TIME, IT CANNOT BE DETERMINED IF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO ARTHREX. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE PRYING AND/OR LEVERAGING ON THE DEVICE DURING USE OR MECHANICAL DAMAGE TO THE DEVICE, SUCH AS DROPPING OR HITTING THE DEVICE WITH ANOTHER DEVICE DURING USE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER.

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THIS IS A FOLLOW-UP SUBMISSION FOR DEVICE EVALUATION. COMPLAINT CONFIRMED. THE EVALUATION REVEALED THAT A PORTION OF THE DEVICE'S DISTAL TIP IS CHIPPED OFF. THE TIP'S EDGE IS DENTED DIAGONALLY FROM THE CHIPPED AREA. ADDITIONALLY, GOUGES AND SCRATCHES WERE OBSERVED ON THE DRILL SLEEVE. THE DEVICE MET ALL MATERIAL SPECIFICATION AS RECEIVED. COMPLAINANT'S EVENT IS TYPICALLY CAUSED BY USER MECHANICAL DAMAGE TO DEVICE SUCH AS HITTING THE DEVICE WITH ANOTHER DEVICE, PRYING/LEVERAGING OR EXCESSIVE BENDING FORCES BEING APPLIED DURING USE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STEPPED RATCHET DRILL SLEEVE, AR-1510FS-7, LOT 051520 ((B)(4)), WAS BEING USED IN AN ACL SOFT TISSUE AUTOGRAFT PROCEDURE. AFTER THE PROCEDURE, THE DEVICE WAS STERILIZED AND RETURNED TO THE DISTRIBUTOR'S OFFICE. UPON RETURN TO THE DISTRIBUTOR, IT WAS NOTED THAT THE TIP OF THE DRILL SLEEVE HAD A CHIP MISSING FROM IT. DURING THE PROCEDURE A FLIP CUTTER AR-1204AS-75, LOT 530659980 ((B)(4)) WAS BEING USED AND SPINNING AT FULL FORCE WHEN DRILLING THE FEMORAL TUNNEL. SALES REP STATES THE CHIP APPEARS ALMOST TO HAVE BEEN BURNED OUT, POSSIBLY BY THE FLIP CUTTER. IT IS UNKNOWN IF THE BROKEN PIECE MAY HAVE REMAINED IN THE PATIENT SINCE THE CHIP WAS NOT NOTICED UNTIL AFTER THE PROCEDURE, AFTER STERILIZATION AND AFTER RETURN TO THE DISTRIBUTOR OFFICE. THE CASE WAS COMPLETED SUCCESSFULLY WITH A COMPOSITE SCREW ON THE TIBIA. NO PATIENT INJURY REPORTED. FLIP CUTTER WILL NOT BE RETURNED AS IT WAS DISCARDED AFTER SURGERY. UPDATE (B)(6) 2016: SALES REP CONFIRMED WITH SURGEON THAT PATIENT HAS HAD NO ISSUES TO DATE AND NO FOLLOW UP X-RAYS HAVE BEEN TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STEPPED RATCHET DRILL SLEEVE, AR-1510FS-7 LOT 051520 ((B)(4)), WAS BEING USED IN AN ACL SOFT TISSUE AUTOGRAFT PROCEDURE. AFTER THE PROCEDURE, THE DEVICE WAS STERILIZED AND RETURNED TO THE DISTRIBUTOR'S OFFICE. UPON RETURN TO THE DISTRIBUTOR, IT WAS NOTED THAT THE TIP OF THE DRILL SLEEVE HAD A CHIP MISSING FROM IT. DURING THE PROCEDURE A FLIP CUTTER AR-1204AS-75 LOT 530659980 ((B)(4)) WAS BEING USED AND SPINNING AT FULL FORCE WHEN DRILLING THE FEMORAL TUNNEL. SALES REP STATES THE CHIP APPEARS ALMOST TO HAVE BEEN BURNED OUT, POSSIBLY BY THE FLIP CUTTER. IT IS UNKNOWN IF THE BROKEN PIECE MAY HAVE REMAINED IN THE PATIENT SINCE THE CHIP WAS NOT NOTICED UNTIL AFTER THE PROCEDURE, AFTER STERILIZATION AND AFTER RETURN TO THE DISTRIBUTOR OFFICE. THE CASE WAS COMPLETED SUCCESSFULLY WITH A COMPOSITE SCREW ON THE TIBIA. NO PATIENT INJURY REPORTED. FLIP CUTTER WILL NOT BE RETURNED AS IT WAS DISCARDED AFTER SURGERY. UPDATE 9/14/16: SALES REP CONFIRMED WITH SURGEON THAT PATIENT HAS HAD NO ISSUES TO DATE AND NO FOLLOW UP X-RAYS HAVE BEEN TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605725 STEPPED, RATCHET DRILL SLEEVE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. 051520 00888867196766

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-1204AS-75, FLIPCUTTER II, SHORT, LOT 530659980