BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM

    MDR report key: 5025967 · Received August 24, 2015

    Report

    Report Number
    2520274-2015-15432
    Event Type
    Injury
    Date Received
    August 24, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 10, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. FIRST DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: LOT NUMBER 4213813 IS NOT A VALID LOT NUMBER FOR PART NUMBER 03.010.104. UNABLE TO PERFORM DHR REVIEW. SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED, THE REPORT INDICATES THAT THE: LOT NUMBER IS UNKNOWN AT SYNTHES (B)(4). 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

    LOT NUMBER WAS IDENTIFIED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART#03.010.104 LOT #U213813, RELEASE TO WAREHOUSE DATE: DECEMBER 23, 2014, 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 THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ON 9/16/15: PRODUCT WAS NOT RETURNED; INVESTIGATIONS COULD NOT BE PERFORMED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EVALUATION METHOD CODE 3317 ADDED FOR DEVICE HISTORY RECORD REVIEW REPORTED IN MEDWATCH FOLLOW UP #1. SYNTHES MANUFACTURING LOCATION CORRECTED. ADDITIONAL NARRATIVE IN INITIAL MEDWATCH STATED A SERVICE HISTORY EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE BUT COULD NOT BE COMPLETED. THIS STATEMENT WAS REPORTED IN ERROR AS THIS DEVICE IS NOT A SERVICEABLE ITEM AND A SERVICE HISTORY EVALUATION WAS NOT PERFORMED. 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

    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 DURING A DISTAL HUMERUS FRACTURE REPAIR. THE DRILL BIT BROKE UNDER TOO MUCH FORCE/STRESS. THERE WAS NO SURGICAL DELAY. A PIECE OF THE INSTRUMENT REMAINED IN THE PATIENT AFTER SURGERY. THERE WAS NO INTENTION OF RETRIEVING THE DRILL BIT FRAGMENT BECAUSE IT WAS TOO DEEP TO REMOVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558251 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM BIT, DRILL HTW SYNTHES MONUMENT U213813

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention