BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWDRIVERS

    MDR report key: 9513607 · Received December 23, 2019

    Report

    Report Number
    8030965-2019-71401
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    December 9, 2019
    Report Date
    December 9, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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 · 0

    CONCOMITANT DEVICE REPORTED: UNKNOWN DHS BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); CORTEX SCREW (PART# 214.038, LOT# L109010, QUANTITY 1); CORTEX SCREW (PART# 214.040, LOT# 9894161, QUANTITY 1); CORTEX SCREW (PART# 214.040, LOT# 9700520, QUANTITY 1); CORTEX SCREW (PART# 214.042, LOT# 9903675, QTY 1); LCP DHS PLATE (PART# 02.224.224S, LOT# L023173 , QUANTITY# 1); DHS/DCS-SCR Ø12.5 L100 OCTAGONAL-COUPL S (PART # 280.301, LOT # UNKNOWN, QTY 1); CONNECSCR F/EXTRACTION DHS BLADE (PART# 03.224.008, LOT# UNKNOWN, QUANTITY# 1).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWDRIVER/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 DURING HARDWARE REMOVAL PROCEDURE FOR RIGHT PROXIMAL FEMUR ON (B)(6) 2019, THE TIP OF THE COUPLING SCREW FOR EXTRACTION DHS BLADE HAS BROKEN OFF IN THE IMPLANT. SURGEON ATTEMPTED TO REMOVE THE DEVICE, BUT WAS NOT ABLE TO ADEQUATELY REMOVE THE SCREW IN THE DHS SYSTEM IN THE FEMORAL NECK COMPONENT. HE SAID THE SCREWDRIVER WAS OF THE INCORRECT SIZE AND THIS HAD HAPPENED BEFORE. THE SCREW WOULD NOT FIT WITH ANY OF THE DHS INSERTION TOOLS OR REMOVAL TOOLS. ALL THE DEVICES WERE EXPLANTED AS PLANNED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN DHS BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN DHS SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN DHS PLATE (PART# 02.224.224S, LOT# L023173 , QUANTITY# 1) THIS REPORT IS FOR ONE (1) UNKNOWN SCREWDRIVER. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305159 UNK - SCREWDRIVERS SCREWDRIVERS HXX OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention LCP DHS-PL 135° 4HO L92 STANDBARREL SST| UNK - NAIL HEAD ELEMENTS: DHS/DCS BLADE| UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW