BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC

    MDR report key: 6523524 · Received April 26, 2017

    Report

    Report Number
    1719045-2017-10350
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Date of Event
    March 29, 2017
    Report Date
    March 30, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    UDI-DI
    07611819682962
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. CONCOMITANT MEDICAL PRODUCTS: PART #: 03.130.010, LOT#: 9881569 (NON-STERILE) - STARDRIVE SCRWDRVER SHFT/T4 50MM/SELF-RETAINING/HXC. NC (B)(4) WAS INITIATED ON (B)(6) 2016 AT INCOMING INSPECTION - I, FOR "SUPPLIER (B)(6). DOES NOT MATCH. ISSUE OF NC IS NOT RELEVANT TO THE COMPLAINT CONDITION "SCREW DRIVER SHAFT WAS DISTORTED". CERTIFICATE OF COMPLIANCE RECEIVED FROM (B)(6) MEET SPECIFICATION. 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. MANUFACTURING LOCATION: SUPPLIER (B)(6), PKG BY (B)(6). MANUFACTURING DATE: APRIL 08, 2016. 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

    A SCREW DRIVER SHAFT WAS USED IN SURGERY ON (B)(6) 2017. THE SURGEON CLAIMED THE SCREW DRIVER SHAFT WAS DISTORTED. NO SURGICAL DELAY AND NO PATIENT HARM REPORTED. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT AND SURGICAL OUTCOME. THIS COMPLAINT INVOLVES 1 PART. CUSTOMER QUALITY (CQ) ENGINEERING INVESTIGATION: THIS COMPLAINT IS CONFIRMED. THE DISTAL STARDRIVE TIP ON THE RETURNED SCREWDRIVER BLADE IS TWISTED AS REPORTED. IT IS TWISTED APPROXIMATELY 10-15 DEGREES IN THE DIRECTION OF RESISTANCE MET DURING SCREW INSERTION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE DISTAL STARDRIVE TIP ON THE RETURNED DEVICE IS ALREADY TWISTED. MOST LIKELY DUE TO INSERTION TORQUE EXCEEDING THE PLASTIC DEFORMATION LIMIT OF THE STARDRIVE TIP. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. THE RETURNED STARDRIVE SCRWDRVR SHFT/T4 50 MM/SELF-RETAINING/HXC IS A REUSABLE INSTRUMENT AVAILABLE FOR USE IN THE VARIABLE ANGLE LOCKING HAND SYSTEM TO AID IN FRAGMENT SPECIFIC FRACTURE FIXATION PER TECHNIQUE GUIDE. THE RED AND YELLOW COLOR CODE BANDS DENOTE INTENDED USE FOR 1.3 MM AND 1.5 MM SCREWS WHICH HAVE A T4 STARDRIVE SCREW HEAD RECESS. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. VISUAL INSPECTION THE DISTAL STARDRIVE TIP ON THE RETURNED SCREWDRIVER BLADE IS TWISTED AS REPORTED. IT IS TWISTED APPROXIMATELY 10-15 DEGREES IN THE DIRECTION OF RESISTANCE MET DURING SCREW INSERTION. DHR 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. DRAWING REVIEW DRAWING WAS REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. 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

    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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2017, IT WAS NOTED THE STARDRIVE SCREWDRIVER SHAFT WAS DISTORTED. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED. THIS REPORT IS FOR ONE (1) STARDRIVER SCREWDRIVER SHAFT THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306061 STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC SCREWDRIVERS HXX SYNTHES MONUMENT 9881569 07611819682962

    Patients

    Seq Age Sex Outcome Treatment
    1