BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE

    MDR report key: 4330142 · Received December 15, 2014

    Report

    Report Number
    1719045-2014-10681
    Event Type
    Injury
    Date Received
    December 15, 2014
    Date of Event
    November 13, 2014
    Report Date
    November 17, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL LOT# REPORTED-P254043/SYNTHES LOT# 5081839. MFG DATE FOR P254043/SYNTHES LOT# 5081839-SEPTEMBER 2005. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PART WAS NOT RETURNED FOR EVALUATION. NO CONCLUSION COULD BE DRAWN, AS THE PART WAS NOT RECEIVED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS FOLLOW-UP REPORT SERVES AS CLARIFICATION OF THE SIX POSSIBLE LOT NUMBERS RELEVANT TO THIS COMPLAINT THAT ALIGN WITH PART NUMBER 03.010.044. THE DEVICE HISTORY REPORTS FOR THE SIX POSSIBLE LOTS ARE INCLUDED BELOW, THE RELEASE TO WAREHOUSE DATE WITHIN THE REPORTS ARE THE RELEVANT MANUFACTURE DATES FOR THE LOTS. DHR 03.010.044 CANNULATED CONNECTING SCREW, LOT U162814. (B)(4). 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

    SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED NOR EXPLANTED.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

    IT WAS REPORTED DURING A TIBIAL NAIL INSERTION PROCEDURE ON (B)(6) 2014 WHILE THE SURGEON WAS DRILLING UNDER FLUOROSCOPY FOR THE DISTAL TARGETING SCREW, THE TIP OF THE DRILL BIT HIT THE TIBIAL NAIL. IT APPEARED AS THOUGH THE MEASUREMENT WAS LESS THAN 0.5MM FROM THE LOCKING HOLE ON THE NAIL. THE SURGEON THEN LOCKED THE PROXIMAL LOCKING SCREW WITHOUT INCIDENT. THE SURGEON THEN REATTEMPTED TO DRILL FOR THE DISTAL LOCKING SCREW AND WAS UNSUCCESSFUL AGAIN. THE SURGEON PROCEEDED TO FREE HANDED THE DISTAL LOCKING SCREW IN PLACE. THERE IS NO DEVICE ALLEGATION AGAINST ANY PRODUCTS. IT WAS NOTED WHEN THE INSERTION HANDLE WAS UNTHREADED FROM THE CONNECTING SCREW THERE WAS A LOT OF SQUEAKING. THIS PROCEDURE WAS COMPLETED WITH A LESS THAN 5 MINUTE SURGICAL DELAY. ADDITIONAL X-RAYS WERE REQUIRED DURING THE PROCEDURE RELATED TO THIS EVENT. THIS IS 6 OF 6 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820405 CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES MONUMENT U162814

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention