BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT TIP T25 DRIVER-LONG

    MDR report key: 6031499 · Received October 14, 2016

    Report

    Report Number
    3003875359-2016-10539
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Report Date
    September 27, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. THE HANDLE OF THE GRAFT PUSHER (CANCELLOUS BONE PUSHER) (394.572, LOT# 4484934) WAS FOUND TO BE BROKEN AT THE DISTAL END. THE DEVICE SHOWS SURFACE SCRATCHES AND WEAR CONSISTENT WITH 14 YEARS OF USE. THE SCREWDRIVER SHAFT STARDRIVE T25, LONG (03.632.401, LOT#9404572) WAS FOUND TO BE BROKEN AT THE DISTAL TIP. THE DEVICE IS OTHERWISE IN GOOD CONDITION WITH MINIMAL SURFACE WEAR. THE SCREWDRIVER SHAFT T25, CANNULATED LONG (03.632.073, LOT#7965064) WAS FOUND TO BE BROKEN AT THE DISTAL TIP. THE DEVICE IS OTHERWISE IN GOOD CONDITION WITH MINIMAL SURFACE WEAR. DRAWINGS FOR GRAFT PUSHER 394.572, SCREWDRIVER SHAFT T25, CANNULATED, 03.632.073, AND SCREWDRIVER SHAFT STARDRIVE T25, LONG, 03.632.401 WERE REVIEWED DURING INVESTIGATION. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE GRAFT PUSHER (CANCELLOUS BONE PUSHER) (394.572, LOT# 4484934) WAS IN USE FOR APPROXIMATELY 14 YEARS. THE ROOT CAUSE OF THE BROKEN HANDLE IS MOST LIKELY DUE TO WEAR AND TEAR ASSOCIATED WITH CONSISTENT USE OVER THE 14 YEAR TIMEFRAME. THE SCREWDRIVER SHAFT STARDRIVE T25, LONG (03.632.401, LOT#9404572). THE ROOT CAUSE IS MOST LIKELY RELATED TO APPLICATION OF EXCESSIVE TORQUE ON THE DRIVER. THE SCREWDRIVER SHAFT T25, CANNULATED LONG (03.632.073, LOT#7965064). THE ROOT CAUSE IS MOST LIKELY RELATED TO APPLICATION OF EXCESSIVE TORQUE ON THE DRIVER. 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

    NO PATIENT INVOLVEMENT REPORTED. EXACT DATE OF EVENT IS UNKNOWN. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW DHR REVIEW REQUEST: PART# 03.632.401, LOT# 9404572, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: MARCH 31, 2015, NO NON CONFORMANCE RECORDS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE 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

    THIS IS REPORT NUMBER 1 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF BOTH THE STRAIGHT TIP T25 DRIVER-LONG AND T25 STARDRIVE SHAFT FOR MATRIX CANNULATED/LONG ARE STRIPPED, AND THE WOODEN HANDLE OF A GRAFT PUSHER 8MM IS FALLING APART. THE PIECES ARE STILL ATTACHED TO THE HANDLE. THE ISSUES WERE DISCOVERED AFTER THE INSTRUMENTS WERE STERILIZED. NO ISSUES WITH THE DEVICES PRIOR TO DISCOVERY. NO CASE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STRAIGHT TIP T25 DRIVER-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682436 STRAIGHT TIP T25 DRIVER-LONG SCREWDRIVERS HXX SYNTHES HAGENDORF 9404572

    Patients

    Seq Age Sex Outcome Treatment
    1