BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2021504 · Received March 17, 2011

    Report

    Report Number
    1030489-2011-00292
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    April 20, 2010
    Report Date
    February 17, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1030489-030112-005-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT FUNCTIONS AS INTENDED WHEN MANUALLY EVALUATED. UNDER POWER, THE ISSUE NOTED IN THE COMPLAINT WAS ABLE TO BE REPLICATED (ADJUSTABLE STOP RELEASED). ADDITIONAL FUNCTIONAL TESTING PERFORMED ON (B)(4) 2011 ON ADDITIONAL LOTS OF THE 876-455, AND THE FAILURE MODE WAS REPLICATED UNDER POWER. WOBBLE NOTED AT DRILLING END WITHOUT POWER ADAPTER ATTACHMENT, INCREASED WOBBLE NOTED WITH POWER DRILL ATTACHMENT. SPRING FORCE OF ASSEMBLY CONTROLLED THROUGH SPRING OUTER DIAMETER, OVERALL LENGTH, WIRE DIAMETER, AND MATERIAL SPECIFICATIONS. (B)(4) QUALITY ACCEPTANCE CRITERIA DOCUMENTS (B)(4) THROUGH C5 CALL FOR FUNCTIONAL CHECK OF SPRING FORCE. ADJUSTABLE DRILL BIT DOES HAVE STRAIGHTNESS WITH 0.1MM CALLOUT; THE RETURNED PRODUCT MEETS THIS SPECIFICATION. ENG. CHANGE MADE ON (B)(4) 2001 TO THE ADJUSTABLE DRILL STOP ((B)(4)) TO INCREASE WIRE DIAMETER AND OVERALL LENGTH OF SPRING, THUS INCREASING RETENTION FORCE. WEAR NOTED AT INTERFACE OF DRILL AND DRILL STOP WHEN USED UNDER POWER IN EXTREME USE CONDITIONS. THIS COULD REDUCE ADJUSTABLE CATCH FEATURES RETENTION FORCE OVER TIME. THE FAILURE ANALYSIS OF THE RETURNED PRODUCT (AND ADDITIONAL PRODUCT TESTING) SUGGESTS INSUFFICIENT RETENTION FORCE OF THE ORIGINAL (B)(4) DRILL STOP SPRING, WHEN UTILIZED IN CONJUNCTION WITH (B)(4) DRILL BIT ADAPTER AND A POWER DRILL.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS RECEIVED IN THE MANUFACTURER FOR EVALUATION. THE EVALUATION IS IN PROCESS. THE FOLLOW UP REPORT WILL BE SENT AFTER THE EVALUATION IS COMPLETED. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGERY FOR C6 CORPECTOMY WITH VP REPLACEMENT IMPLANT AT C6 AND THE ANTERIOR FIXATION PLATE AND SCREWS AT C5-C7. THE POWER DRILL WITH THE DRILL BIT AND ADJUSTABLE DRILL STOP SET AT 14MM. WHILE DRILLING AT C5, THE ADJUSTABLE DRILL STOP CAME APART AND IT WAS ENDED UP DRILLING BEYOND THE DEPTH INTENDED. AT THE TIME OF THE EVENT IT WAS UNKNOWN IF THERE WAS ANY INJURY TO THE PATIENT. UPON COMPLETION OF THE SURGERY AND AFTER THE PATIENT WAS AWAKE THERE WAS NOT INDICATION THAT THERE WAS ANY INJURY TO THE PATIENT. LATER UPDATED INFORMATION STATES THAT THE DRILL BIT WAS WOBBLING WHILE USING WITH THE POWER DRILL. THE USER HAD TO HOLD THE DILL BIT THAT WAS WHEN THE DILL STOP CAME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WARSAW ORTHOPEDIC, INC. NA 33861

    Patients

    Seq Age Sex Outcome Treatment
    1 DRILL BIT