BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM

    MDR report key: 6961530 · Received October 19, 2017

    Report

    Report Number
    3003875359-2017-10518
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Report Date
    August 23, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    UDI-DI
    10886982068941
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT WAS REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. RETURNED TO MANUFACTURER. DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 24 FEB 2015. NO 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. CUSTOMER QUALITY (CQ) CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. THE FOLLOWING DEVICE WAS RETURNED TO CQ: PART #: 03.010.473. LOT #: 9171664. QUANTITY: 1. THE RETURNED DRIVER IS NOT BENT. THE DISTAL TIP IS STRIPPED AND THE SLIDING BAR SHOWS SIGNS OF NORMAL WEAR AND TEAR. THIS COMPLAINT IN CONFIRMED. A VISUAL INSPECTION, DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE INSTRUMENT IS ALREADY DAMAGED. THE 03.010.473 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM SCREWDRIVER IS INTENDED FOR INSERTION AND REMOVAL OF DISTAL LOCKING SCREWS DURING FEMORAL AND TIBIAL NAIL PROCEDURES. DHR REVIEW FOR PART 03.010.473 AND LOT # 9171664. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 24.FEB.2015. NO 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. DRAWINGS WERE REVIEWED AND WERE DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. DIMENSIONAL ANALYSIS FOR THE INSTRUMENTS IS NOT APPLICABLE DUE TO POST-MANUFACTURING DAMAGE. A MATERIAL AND HARDNESS IS NOT APPLICABLE AT THIS TIME AS THE DEVICES WENT THROUGH THOSE TESTS DURING THE INSPECTION TESTING AT THE TIME ON MANUFACTURING AND THE DHR RECORDS SHOWED NO ISSUES. NO DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE COMPLAINT ARE UNKNOWN, HOWEVER A POSSIBLE CAUSE COULD BE OVER TORQUEING AS WELL AS NORMAL WEAR AND TEAR FOR A MULTI-USE INSTRUMENT. 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

    IT WAS REPORTED THAT A SCREWDRIVER WAS FOUND BENT WHILE GOING THROUGH INVENTORY. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. INVESTIGATION OF THE RETURNED DEVICE REVEALED IT IS NOT BENT BUT THE DISTAL TIP IS STRIPPED AND THE SLIDING BAR SHOWS SIGNS OF WEAR AND TEAR. THIS COMPLAINT IS FOR ONE (1) INTER-LOCK SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740905 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM SCREWDRIVERS HXX SYNTHES HAGENDORF 9171664 10886982068941

    Patients

    Seq Age Sex Outcome Treatment
    1