BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 6825371 · Received August 28, 2017

    Report

    Report Number
    1719045-2017-10851
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 7, 2017
    Report Date
    August 8, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWE
    UDI-DI
    10886982186317
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT IDENTIFIER: (B)(6). PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODES: GFF, GFA, HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DHR REVIEW FOR PART #310.25, SYNTHES LOT#U211802. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEASE TO WAREHOUSE DATE: 13-NOV-2014, 14-NOV-2014. SUPPLIER: (B)(4). 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.

    Additional Manufacturer Narrative · 1

    UPDATED INFORMATION: CONCOMITANT DEVICE REPORTED/ADDED. THERAPY DATE IS UNKNOWN. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    CUSTOMER QUALITY COMPLETED AN INVESTIGATION OF THE RETURNED DEVICE. THE 310.25, LOT NUMBER U211802, 2.5MM DRILL BIT/QC/GOLD/110MM WAS RETURNED WITH A BROKEN DRILL BIT TIP. APPROXIMATELY 18 MM OF THE DRILL BIT TIP IS BROKEN OFF AND THE FRAGMENT WAS RETURNED. THIS COMPLAINT IS CONFIRMED. A VISUAL INSPECTION, DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICE ALREADY HAS A BROKEN TIP. THE 310.25 2.5MM DRILL BIT/QC/GOLD/110MM IS AN INSTRUMENT ROUTINELY USED TO PREDRILL BONE FOR SCREWS. THE DEVICE WAS RETURNED AND IT WAS REPORTED THAT "THE DRILL BIT BROKE" THIS CONDITION IS CONFIRMED; THE INSTRUMENT WAS RETURNED WITH A BROKEN DRILL BIT TIP. APPROXIMATELY 18 MM OF THE DRILL BIT TIP IS BROKEN OFF AND THE FRAGMENT WAS RETURNED. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO EXCESSIVE FORCE, EXPOSURE TO DENSE BONE AND/OR CONSISTENT USE AND CUMULATIVE WEAR OVER THE PART'S LIFETIME, CAUSING MATERIAL FATIGUE AND BREAKAGE. DHR REVIEW FOR PART #310.25, SYNTHES LOT#U211802 NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. A DCRM REVIEW AND/OR OCCURRENCE RATE CALCULATION MUST BE PERFORMED FOR ALL COMPLAINT PARTS WHICH RESULTED IN A CLASSIFICATION OF SERIOUS INJURY THAT WERE NOT GENERATED FROM A LITERATURE ARTICLE. THEREFORE, NO DCRM CALCULATION WILL BE PERFORMED FOR THIS COMPLAINT. 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 DURING A LEFT FEMORAL HEMIARTHROPLASTY ON (B)(6) 2017, THE DRILL BIT BROKE. THE SURGEON REMOVED THE FRAGMENTS AND THE X-RAY CONFIRMED ALL FRAGMENTS WERE RETRIEVED. THERE WAS AN APPROXIMATE 60-MINUTE SURGICAL DELAY. ANOTHER DRILL BIT WAS AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE:9/6/17- MAUDE REPORT- MW5071682 RECEIVED VIA EMAIL INTO CUSTOMER QUALITY. FACILITY CONTACT NAME, TITLE AND PHONE NUMBER ADDED TO COMPLAINT FOR (B)(6). LOT # IN REPORT IS 0211802 BUT LOT # U211802 IS CONFIRMED ON PRODUCT PICTURES. NARRATIVE IN REPORT REPORTS 2.0MM DRILL BIT BROKE BUT PER JDE PART # 310.25, IT WAS A 2.5MM DRILL BIT. CONCOMITANT DEVICE REPORTED: DRILL (UNKNOWN PART AND LOT NUMBER, QUANTITY X1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603941 2.5MM DRILL BIT/QC/GOLD/110MM INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES MONUMENT U211802 10886982186317

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR