BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.3MM DRILL BIT

    MDR report key: 8679976 · Received June 7, 2019

    Report

    Report Number
    8030965-2019-65061
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    May 13, 2019
    Report Date
    May 13, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    GFG
    UDI-DI
    07611819657373
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORDS: DEVICE HISTORY LOT, PART: 03.168.011, LOT: F-24448, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 16.AUGUST 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY: INVESTIGATION SELECTION, INVESTIGATION SITE: (B)(4), SELECTED FLOW: DEVICE INTERACTION/ FUNCTIONAL. VISUAL INSPECTION: THE VISUAL INSPECTION HAS SHOWN THAT THE RETURNED DRILL BIT IS ALMOST IN NEW CONDITION WITH NO DAMAGE. THERE ARE SLIGHTLY SIGNS OF USE AT THE CUTTING EDGES VISIBLE. ALL FEATURES, RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO DEVICE MALFUNCTION COULD BE OBSERVED. FUNCTIONAL TEST: BECAUSE THE RELEVANT MATING PARTS WERE NOT RETURNED FOR INVESTIGATION, NO FUNCTIONAL TEST COULD BE PERFORMED. AS STATED IN THE NOTE ON PC LEVEL, DEVICES FROM OTHER COMPANIES WERE USED IN COMBINATION WITH THE DRILL BIT, SUCH AS K-WIRE MADE BY MIZUHO AND THE PROTECTION SLEEVE S-FLX-144-00 MADE BY FUJI FLEX. SUMMING UP IT CAN BE STATED THAT THE SURGICAL PROCEDURE WAS IN CONTRAST TO THE CURRENT SURGICAL TECHNIQUE AS WE CAN ONLY GUARANTEE THE FUNCTIONALITY OF THE ENTIRE SYSTEM IN RELATION WITH DEPUY SYNTHES PRODUCTS. DRAWING/SPECIFICATION REVIEW: 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. IN ADDITION SURGICAL TECHNIQUE GUIDE FOR FNS, WAS CONSULTED FOR FUNCTIONALITY MATTERS. SUMMARY: THE AVAILABLE DATA DOES NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE COMPLAINT CONDITION, AND THERE IS NO EVIDENCE TO SUPPORT THE ALLEGATION MADE IN THE COMPLAINT. BY THE REPORTED FACT, THAT DEVICES FROM ANOTHER COMPANY WERE USED DURING THE SURGICAL PROCEDURE, THE SYSTEM ENCOUNTERED CERTAINLY INTERACTION ISSUES WHICH FINALLY COULD HAVE CAUSED THE MALFUNCTION/ FAILURE OF THE SYSTEM. BASED ON THE INVESTIGATION OUTCOME, THE REPORTED ADVERSE EVENT WAS LIKELY CAUSED BY THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS.THE ROOT CAUSE WAS IDENTIFIED DURING THE PERFORMED CQ EVALUATION AND THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. BASED ON THE INVESTIGATION FINDINGS, 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

    THE DEVICE WAS 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 ON (B)(6) 2019, DURING AN OSTEOSYNTHESIS SURGERY FOR FEMORAL NECK FRACTURES USING WITH A FEMORAL NECK SYSTEM (FNS), THE REAMER INTERFERED WITH THE PROTECTION SLEEVE AND AN UNKNOWN K-WIRE AND SYNTHES DRILL BIT BROKE. THE SURGEON CHECKED IF THERE WERE FRAGMENTS IN THE PATIENT'S BODY, BUT NO FRAGMENTS WERE FOUND INTRAOPERATIVELY. AFTER THE SURGERY, METAL DEBRIS WAS CONFIRMED ON LATERAL SIDE VIA X-RAYS. THE FRAGMENTS WILL BE REMOVED WHEN IMPLANTS WILL BE REMOVED IN THE FUTURE. THERE WAS NO SURGICAL DELAY. SURGICAL PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: GUIDE WIRE (PART# 357.399S, LOT# 2L42266, QUANTITY 1), UNKNOWN K-WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN PROTECTION SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473305 4.3MM DRILL BIT BIT, MILLING STERILE AND NON GFG OBERDORF SYNTHES PRODUKTIONS GMBH F-24448 07611819657373

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDEWIRE Ø3.2 L400| UNK - GUIDE/COMPRESSION/K-WIRES| UNK - GUIDES/SLEEVES/AIMING: SLEEVE| GUIDEWIRE Ø3.2 L400| UNK - GUIDE/COMPRESSION/K-WIRES| UNK - GUIDES/SLEEVES/AIMING: SLEEVE