BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 5872429 · Received August 12, 2016

    Report

    Report Number
    1719045-2016-10606
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    July 26, 2016
    Report Date
    July 26, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: GFF, GFA, HSZ. LOT NUMBER INITIALLY PROVIDED AS 0243991; THAT NUMBER IS NOT ABLE TO BE VERIFIED, MOST LIKELY CORRECT LOT NUMBER IS U243991. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS IT WAS REPORTEDLY DISCARDED BY THE FACILITY. PART 310.25, LOT U243991: RELEASE TO WAREHOUSE DATE: MAY 09, 2016. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 PATIENT UNDERWENT A RIGHT TIBIA PLATEAU SURGERY ON (B)(6) 2016 FOR THE IMPLANTATION OF A VARIABLE ANGLE PROXIMAL TIBIA PLATE AND SIX SCREWS. IT WAS REPORTED THAT WHILE THE SURGEON WAS DRILLING AT AN EXTREME ANGLE, WITHOUT THE USE OF A TISSUE PROTECTOR, THE TIP OF A 2.5MM DRILL BIT HIT THE SIDE HOLE OF THE PLATE AND A FEW MILLIMETERS OF THE TIP BROKE OFF. THE BROKEN TIP WAS RETRIEVED WITHOUT ISSUE. IT WAS REPORTED THAT THE DRILLING WAS COMPLETE AND THEREFORE, NO FURTHER ACTION WAS NEEDED. THE SURGERY WAS DELAYED APPROXIMATELY ONE MINUTE. THE REMAINDER OF THE SURGERY WENT AS PLANNED AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICE: VARIABLE ANGLE PROXIMAL TIBIA PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523317 2.5MM DRILL BIT/QC/GOLD/110MM INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES MONUMENT U243991

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR