BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM DRILL BIT/MINI QC/65MM

    MDR report key: 7126635 · Received December 18, 2017

    Report

    Report Number
    2939274-2017-50356
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    November 19, 2017
    Report Date
    November 19, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HWE
    UDI-DI
    10886982185983
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: GFA, GFF, HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    DHR REVIEW COMPLETED. PART # 310.141 SYNTHES LOT # U250735 SUPPLIER LOT # (B)(4) EXPIRATION DATE: N/A RELEASE TO WAREHOUSE DATE: 05 AUG 2016 SUPPLIER: (B)(4) NO NCR¿S 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 SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. THE RETURNED DRILL BIT (PART 310.141, LOT U250735, MFG 05 AUG 2016) WAS INSPECTED AT CUSTOMER QUALITY AND THE COMPLAINT WAS CONFIRMED. WHETHER THIS COMPLAINT COULD BE REPLICATED IS NOT APPLICABLE BECAUSE THE DEVICE WAS RETURNED BROKEN. THE FOLLOWING WERE PERFORMED TO COMPLETE THE INVESTIGATION. ¿ VISUAL INSPECTION ¿ DEVICE HISTORY RECORD REVIEW ¿ DRAWING REVIEW ¿ DIMENSIONAL ANALYSIS MATERIAL AND HARDNESS TESTING IS NOT APPLICABLE AT THIS TIME AS THEY WERE TESTED AT THE TIME OF MANUFACTURED AND CONFIRMED TO HAVE NO ISSUES THROUGH THE DHR REVIEW. UPON VISUAL INSPECTION, THE DRILL BIT WAS NOTED TO BE BROKEN. FRAGMENT WAS NOT RETURNED. DHR REVIEW SHOWED NO NCR¿S WERE GENERATED DURING PRODUCTION. DRAWING (CURRENT AND MFG) WAS REVIEWED AND WERE DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE DIAMETER OF THE SHAFT CLOSEST TO THE BREAK WAS MEASURED TO BE WITH IN THE SPECIFICATION OF 1.475 TO 1.50MM AT 1.49MM BASED ON DRAWING. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION THEREFOR NO FURTHER CORRECTIVE AND PREVENTIVE ACTIONS ARE PROPOSED. DUE TO THE SERIOUS INJURY DESIGN AND CLINICAL RISK MANAGEMENT (DCRM) DOCUMENT WAS REVIEWED. THE COMPLAINT IS ADEQUATELY ADDRESSED BY THE RISK ASSESSMENT. 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 AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RADIUS ON (B)(6) 2017, 1.5MM DRILL BIT / MINI BROKE. THE FRAGMENT STILL REMAINS IN THE PATIENT. THERE IS NO REPORT OF SURGICAL DELAY OR PATIENT HARM. SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 2.0MM TITANIUM CORTEX SCREW SELF-TAPPING 14MM (401.814.96, LOT UNKNOWN, QUANTITY 1). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904609 1.5MM DRILL BIT/MINI QC/65MM INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH HWE WRIGHTS LANE : SYNTHES USA PRODUCTS LLC U250735 10886982185983

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention