BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13.0MM CANNULATED DRILL BIT 300MM

    MDR report key: 6915569 · Received October 5, 2017

    Report

    Report Number
    1719045-2017-11013
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 14, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSZ
    UDI-DI
    10886982193797
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE & WEIGHT NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THE: DHR REVIEW: PART # 351.27, SYNTHES LOT # U110553, SUPPLIER LOT # U110553. RELEASE TO WAREHOUSE DATE: 07 OCT 2009. 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 SUBCOMPONENTS, 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 · 1

    CONCOMITANT MEDICAL PRODUCTS: A STRYKER 7000 DRILL (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY: 1). DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: HWE, GFA, GFF. A PRODUCT INVESTIGATION WAS PERFORMED. THIS COMPLAINT IS CONFIRMED, THE DEVICE WAS RETURNED BROKEN IN TWO PIECES. A VISUAL INSPECTION, DIMENSIONAL ANALYSIS, AND DRAWING REVIEW WERE CONDUCTED AS PART OF THIS INVESTIGATION. VISUAL INSPECTION AT CUSTOMER QUALITY (CQ) CONFIRMED THE REPORTED COMPLAINT DESCRIPTION. THE DEVICE WAS RECEIVED AT CQ IN TWO PIECES. A PIECE, 19.85 MM, BROKE OFF THE PROXIMAL END OF THE DRILL BIT. FURTHER DIMENSIONAL ANALYSIS OF THE INNER AND OUTER DIAMETER OF THE DEVICE WERE NOT APPLICABLE DUE TO POST MANUFACTURE MALFORMATION. THE MATERIAL AND RELEVANT MATERIAL PROPERTIES WERE DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR. NO FURTHER MATERIAL TESTING WILL BE CONDUCTED. RELEVANT DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE DEVICE COULD HAVE BEEN USED AT AN ANGLE OR OFF AXIS. ADDITIONALLY, IT WAS NOTED THAT THE SURGEON WAS USING A STRYKER POWER DRILL. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE INSTRUMENT IS ALREADY BROKEN. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 · 1

    IT WAS REPORTED THAT A DRILL BIT BROKE OFF INTO A DRILL CHUCK DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) INTRAMEDULLARY NAIL INSERTION OF THE FEMUR ON (B)(6) 2017. THE DRILL BIT BROKE INTO TWO PIECES AS THE SURGEON WAS DRILLING. THE DRILL USED WAS A STRYKER 7000. THERE WAS NO REPORTED SURGICAL DELAY. FRAGMENTS DID FALL INTO THE PATIENT; BUT,WERE REPORTED AS EASILY REMOVED AND CAUSED NO DELAY OR INTERNAL DAMAGE. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A NEW DRILL BIT. A NAIL AND (4) 5.0MM LOCKING SCREWS WERE IMPLANTED IN THE PATIENT AFTER THE DRILL BIT BROKE. THE PATIENT OUTCOME WAS REPORTED AS GREAT. A REPLACEMENT WAS REQUESTED. CONCOMITANT DEVICES REPORTED: A STRYKER 7000 DRILL (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY: 1). THIS REPORT INVOLVES 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698663 13.0MM CANNULATED DRILL BIT 300MM INSTR,SURGICAL,ORTHO,PNEUMATIC POWERED & ACCESSORY/ATTACHMENT HSZ SYNTHES MONUMENT U110553 10886982193797

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR