BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE

    MDR report key: 3162580 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-03041
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K962913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE MEASURABLE DIMENSIONS OF THE BROKEN DRILL BITS WERE CHECKED AND 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 ISO 5832-1. UNFORTUNATELY, THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. NEVERTHELESS, A MANUFACTURING RELATED CONDITION CAN BE EXCLUDED AND WE ASSUME THAT HIGH APPLIED FORCES OR METAL CONTACT CAUSED THE BREAKAGES. PLACEHOLDER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED: DRILL BIT BROKE OFF DURING DRILLING. THE DRILL BIT 2.0 BROKE OFF DURING DRILLING OVER THE K-WIRE IN LITTLE PIECES DURING THE SURGERY. TRYING TO FIX A LITTLE FRAGMENT. THE LITTLE PIECES HAD TO BE REMOVED OUT OF THE PATIENT, BUT STILL SOME PIECES ARE IN THE PATIENT. SURGICAL INTERVENTION CHANGED INTO PLATES AND SCREWS INSTEAD OF IM NAIL. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262726 DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE HWE SYNTHES GMBH F-13358

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention