BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

    MDR report key: 8405512 · Received March 8, 2019

    Report

    Report Number
    8030965-2019-61851
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Report Date
    February 15, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819760899
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 03.010.061, LOT: 9081156. MANUFACTURING LOCATION: BETTLACH, MANUFACTURING DATE: AUG 29, 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. THE USED MATERIAL WAS STAINLESS STEEL 440A AS REQUIRED AND THE MEASURED HARNESS WAS WITH 53.8 ¿ 54.3 HRC WITHIN THE SPECIFICATION OF 52 0/+3 HRC. PRODUCT INVESTIGATION WAS COMPLETED. THE RECEIVED DRILL BIT SHOWS THAT QUICK COUPLING AT THE PROXIMAL END IS BROKEN OFF. THE BROKEN OFF PORTION IS MISSING. FURTHERMORE, THE TIP AND THE CUTTING EDGES OF THE DRILL BIT ARE BADLY WORN. THE USED MATERIAL WAS STAINLESS STEEL 440A AS REQUIRED AND THE MEASURED HARNESS WAS WITH 53.8 ¿ 54.3 HRC WITHIN THE SPECIFICATION OF 52 0/+3 HRC. THE BROKEN SURFACE IS HOMOGENEOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. THE RECEIVED CONDITION OF THE DEVICE IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. WE ONLY CAN ASSUME THAT A COMBINATION BETWEEN INTENSE USE AND A MECHANICAL OVERLOAD DURING USE, OR IMPROPER HANDLING DURING THE CLEANING PROCESS DID LEAD TO BREAKAGE OF THE DEVICE. WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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

    THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING DECONTAMINATION, THE DRILL BIT WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.2MM THREE-FLUTED DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196764 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION BIT,DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH 9081156 07611819760899

    Patients

    Seq Age Sex Outcome Treatment
    1