BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT Ø4.2 CALIBR L145 3FLUTE

    MDR report key: 3072943 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-01859
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO ASIF SPECIFICATIONS AND WITH THE INTERNATIONAL STANDARD. THE SHAFT OF THE BROKEN DRILL BIT SHOWS MARKS OF USE AND WEAR, WHAT IS CONSISTENT WITH THE EVENT DESCRIPTION THAT THE INSTRUMENT WAS BENT DURING DRILLING. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE, WHAT INDICATES MATERIAL CONFORMITY AS WELL. TAKING INTO ACCOUNT ALL RELEVANT FINDINGS, WE ASSUME THAT THE DRILL BIT BROKE DURING USE DUE TO MECHANICAL OVERLOAD. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A FEMORAL NAIL INSERTION PROCEDURE, A 4.2MM DRILL BIT BROKE WHEN THE SURGEON WAS TRYING TO DO A DISTAL LOCK. ABOUT 2.4MM OF THE DRILL BIT BROKE INSIDE OF THE BONE. THE SURGEON TRIED TO REMOVE THE BROKEN PART, BUT HIS ATTEMPT JUST MOVED THE DRILL BIT FURTHER INTO THE MEDULLARY CANAL. HE THEN GAVE UP AND DECIDED TO LEAVE THE DRILL BIT IN PATIENT'S BONE. IT IS REPORTED THAT THERE WAS ABOUT A 15 MINUTE DELAY IN SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173277 DRILL BIT Ø4.2 CALIBR L145 3FLUTE HTW SYNTHES GMBH 2635950

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention