BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.1 L70/39 F/CORE HOLE

    MDR report key: 9350271 · Received November 20, 2019

    Report

    Report Number
    8030965-2019-70444
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    November 5, 2019
    Report Date
    November 5, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07612334090744
    PMA / PMN Number
    EXEMPT
    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. DHR REVIEW FOR STERILIZATION PROCESS: PART NUMBER: 03.130.200S, LOT NUMBER: L023841, MANUFACTURING SITE: SELZACH, SUPPLIER: FRÜH VERPACKUNGSTECHNIK AG, RELEASE TO WAREHOUSE DATE: 17. JUNE 2016, EXPIRY DATE: 01.JUNE 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DHR FOR NON STERILE PRODUCT: PART NUMBER: 03.130.200, LOT NUMBER: F-19543, MANUFACTURING SITE: SELZACH, SUPPLIER: SPHINX WERKZEUGE AG, RELEASE TO WAREHOUSE DATE: 20. MAI 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR DISTAL RADIUS FRACTURE WITH A VA HAND AND TWO DRILL BITS IN QUESTION. AFTER THE SURGEON TEMPORARILY FIXED THE PALMAR SIDE BONE FRAGMENT (5MM FROM THE ARTICULAR SURFACE) WITH A K-WIRE, THE SURGEON TRIED TO FIX THE PLATE. DURING THE DRILLING, THE DRILL BIT (03.130.200S) BROKE. THE SURGEON REMOVED THE PLATE ONCE, AND REMOVED THE FRAGMENT OF THE DRILL BIT. WHILE DRILLING THE OTHER HOLE, THE DRILL BIT (03.130.202S) BROKE. THE SURGEON COULD REMOVE THE FRAGMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON CONFIRMED BY X-RAYS THAT NO FRAGMENT REMAINED IN THE BODY. THE SURGERY WAS DELAYED BY LESS THAN 30-MINUTES. THE SURGEON COMMENTED THAT THE BREAKAGES OF THE DRILL BITS WERE UNAVOIDABLE BECAUSE THE DRILL BITS WERE ORIGINALLY DESIGNED FOR HAND. THE SURGEON DECIDED TO USE THE PLATE, BECAUSE HE THOUGHT THAT THE PLATE WAS NEEDED TO DEAL WITH THE FRACTURE. THE SURGEON KNEW THE RISK OF THE BREAKAGE OF THE IMPLANT AFTER THE SURGERY. THE SURGEON WILL PERFORM AFTER-TREATMENT CONSIDERING THE RISK. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - GUIDE/COMPRESSION/K-WIRES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1), UNK - PLATES: HAND (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/K-WIRE ATTACHMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141809 DRILL BIT Ø1.1 L70/39 F/CORE HOLE DRILL BIT HTW OBERDORF SYNTHES PRODUKTIONS GMBH L023841 07612334090744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - GUIDE/COMPRESSION/K-WIRES| UNK - PLATES: HAND