BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM

    MDR report key: 7164772 · Received January 4, 2018

    Report

    Report Number
    8030965-2018-50069
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 7, 2017
    Report Date
    December 7, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819274112
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 310.509, SYNTHES LOT NUMBER: L488210: RELEASE TO WAREHOUSE DATE: 14.JUL.2017, MANUFACTURING SITE: (B)(4): NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. THE INVESTIGATION HAS SHOWN THAT THE RECEIVED DRILL BIT IS BROKEN AS MENTIONED IN COMPLAINT DESCRIPTION. FURTHERMORE WE FOUND THE DRILL BIT'S FLUTE TWISTED. HOWEVER, DUE TO THIS RECEIVED CONDITION THIS COMPLAINT WILL BE RATED AS CONFIRMED. THE MANUFACTURING REVIEW DOES SHOW THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FOR MATERIAL AND HARDNESS ANALYSIS THE MANUFACTURING PAPERS OF THE SEMI-FINISHED PART 60036882, WHICH IS A COMPONENT OF 310.509, WAS PERFORMED. THE INVOLVED WORK ORDERS WERE PRODUCED ON JUNE 20 2017 AND JUNE 14 2017. THE RESULT OF THE REVIEW IS THAT THE CORRECT MATERIAL 440A WAS USED AND THE REQUIRED HARDNESS WAS WITHIN SPECIFICATION. THE BROKEN SURFACE IS HOMOGENEOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. THE COMPLAINT RELEVANT DIMENSIONS WERE CHECKED AS FAR AS POSSIBLE AND FIND TO BE WITHIN SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. WE ONLY CAN ASSUME THAT A BLOCKAGE IN COMBINATION WITH TOO MUCH MECHANICAL FORCE CAUSED THE BREAKAGE OF THE DRILL BIT. FINALLY WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE'S. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 INFORMATION IS UNKNOWN. 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. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, THE DEVICE WAS USED IN SURGERY FOR RADIAL HEAD FRACTURE. DURING THE SURGERY THE SURGEON INSERTED TWO SCREWS TO FIX A RADIAL HEAD PROSTHESIS (RHP) RIM PLATE. AFTER THAT, THE SURGEON DRILLED AT THE SECOND HOLE FROM DISTAL OF THE PLATE, USING DRILL GUIDE. HE TRIED TO PULL OUT THE DRILL BIT WHILE DRILLING IN A REVERSE ROTATION THOUGH HE FELT A STRONG RESISTANCE. THEN, HE NOTICED THAT THE DRILL BIT WAS BROKEN AND IT WAS LEFT IN THE DRILL GUIDE. NO BROKEN PARTS WERE FOUND LEFT IN THE BODY, AND THE SURGERY WAS COMPLETED WITHOUT ANY EXTENSION. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE: RADIAL HEAD PROSTHESIS PLATE (PART/LOT UNKNOWN, QUANTITY 1); DRILL GUIDE (PART/LOT UNKNOWN, QUANTITY 1) THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7470 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM BIT, DRILL HTW OBERDORF : SYNTHES PRODUKTIONS GMBH L488210 07611819274112

    Patients

    Seq Age Sex Outcome Treatment
    1