BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/180MM

    MDR report key: 5940463 · Received September 9, 2016

    Report

    Report Number
    3003506883-2016-10154
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    August 25, 2016
    Report Date
    August 25, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE USED: GFF, GFA, HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED TO MANUFACTURER. CONCOMITANT MEDICAL PRODUCT: UNKNOWN SCREW - UNKNOWN PART AND LOT NUMBERS, QUANTITY: 1; THERAPY DATE: (B)(6) 2016. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: PART MANUFACTURING DATE: 08-JUN-2016. PART EXP. DATE: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# H099632 OF 2.5MM DRILL BIT/QC/GOLD/180MM WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DRILL BLANK DEVICE HISTORY RECORD REVEALED THIS LOT (H051741) MET ALL SPECIFICATIONS. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT (7973522) MET ALL SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE ON (B)(6) 2016 TO TREAT A RIGHT ANKLE FRACTURE. DURING THE PROCEDURE WHILE THE SURGEON WAS INSERTING LONG SCREWS INDEPENDENT OF THE 7-HOLE PLATE, THE TIP OF THE DRILL BIT BROKE. THERE WAS NO INTERVENTION TO REMOVE THE FRAGMENT TIP THAT WAS RETAINED. AN X-RAY TAKEN AT THE TIME SHOWED THE FRAGMENT FINDING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED IN STABLE AFTER THE PROCEDURE. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN SCREW - UNKNOWN PART AND LOT NUMBERS, QUANTITY: 1. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/180MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590112 2.5MM DRILL BIT/QC/GOLD/180MM INSTR, SURGICAL ORTHOPEDIC, AC-POWERED MOTORED/ACCESS & ATTACH HWE SYNTHES ELMIRA H099632

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention