BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM DRILL BIT/QC/165MM

    MDR report key: 6791552 · Received August 14, 2017

    Report

    Report Number
    9612488-2017-10401
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 17, 2017
    Report Date
    July 20, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    UDI-DI
    07611819245891
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED. THE REPORTED DRILL BIT (PART 310.284 / LOT 9801647) WAS RECEIVED FOR INVESTIGATION. THE VISUAL INSPECTION HAS SHOWN THAT APPROX. 15MM FROM THE FLUTED TIP SECTION IS BROKEN OFF. THE BROKEN OFF PORTION WAS NOT RETURNED. THE Ø2.8 OF THE DRILL BIT GOT MEASURED PER RELEVANT DRAWING AND THE MEASURING RESULT DOES SHOW CONFORMITY. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE USED MATERIAL WAS STAINLESS STEEL PER ISO 7153 AS REQUIRED AND THE MEASURED HARNESS WAS WITHIN THE SPECIFICATION. THE BROKEN SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. WE ONLY CAN ASSUME THAT A MECHANICAL OVERLOADING SITUATION, FOR EXAMPLE METALLIC CONTACT OR LATERAL STRESS, HAS CAUSED THE BREAKAGE. PLEASE ALSO NOTE; BLUNT DRILL BITS REQUIRE MORE MECHANICAL POWER DURING THE APPLICATION, THEREFORE WE WOULD LIKE TO DRAW YOUR ATTENTION IN THE LEAFLET OF THE RELEVANT TECHNIQUE GUIDE ¿IMPORTANT INFORMATION¿: CHECK INSTRUMENTS FOR SOUND SURFACES, AND CORRECT ADJUSTMENT AND FUNCTION. DO NOT USE SEVERELY DAMAGED INSTRUMENTS, INSTRUMENTS WITH UNRECOGNIZABLE MARKINGS, CORROSION, OR BLUNT CUTTING SURFACES. BASED ON THE MANUFACTURING INVESTIGATION RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO INDICATION FOR PRODUCT RELATED ISSUE 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

    PATIENT ID, DATE OF BIRTH AND WEIGHT WERE NOT PROVIDED FOR REPORTING. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. INITIAL REPORTER CONTACT NUMBER: (B)(6). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 310.284, LOT# 9801647. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JAN 18, 2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 ON (B)(6) 2017, DURING THE SURGERY THE DRILL BIT BROKE. NO DELAY TO SURGERY TIME REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572370 2.8MM DRILL BIT/QC/165MM BIT,DRILL HTW SYNTHES BETTLACH 9801647 07611819245891

    Patients

    Seq Age Sex Outcome Treatment
    1