BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM

    MDR report key: 3845008 · Received June 3, 2014

    Report

    Report Number
    9612488-2014-10200
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE HISTORY RECORDS REVIEW REVEALED THAT THE MEASURABLE DIMENSIONS OF THE RETURNED DRILL BIT WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. WE FOUND THAT THE TIP OF THE DRILL BIT IS INDEED COMPLETELY BROKEN OFF. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE, WHICH INDICATES MATERIAL CONFORMITY AS WELL. CONSIDERING ALL RELEVANT FINDINGS IT IS LIKELY THAT THE DRILL BIT BROKE DUE TO A MECHANICAL OVER-LOADING SITUATION WHILE USE. POSSIBLY THE DRILL BIT WAS EXPOSED TO EXTENDED LATERAL STRESS OR GOT IN CONTACT WITH OTHER METALLIC PARTS. NEITHER A PRODUCT NOR A MATERIAL RELATED FAULT WAS FOUND. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHILE DOING THE DISTAL LOCKING FOR THE MULTILOCK HUMERAL NAIL THE DRILL BIT TIP BROKE OFF INSIDE THE PATIENT. THE SURGEON OPENED AN EXTRA INCISION IN ORDER TO TAKE IT OUT BUT WAS NOT ABLE TO FIND IT SO THE SURGEON DECIDED TO KEEP IT INSIDE THE PATIENT. THE SURGEON USED THE OTHER INCISION TO FIX THE NAIL DISTALLY. THE SURGERY WAS DELAYED FOR THIRTY MINUTES. THE PATIENT IS REPORTEDLY DOING WELL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323751 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM BIT, DRILL HTW SYNTHES BETTLACH 8022111

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention