BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6660804 · Received June 22, 2017

    Report

    Report Number
    1719045-2017-10592
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    May 29, 2017
    Report Date
    May 29, 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

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. REPORTER FACILITY CONTACT NUMBER WAS NOT PROVIDED FOR REPORTING. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.130.010, LOT# 9881569. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: APR 08, 2016. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THIS COMPLAINT IS CONFIRMED. THE DEVICE WAS RECEIVED AT CUSTOMER QUALITY (CQ) WITH A PORTION OF THE DISTAL TIP SHEARED OFF. THE SHEARED OFF FRAGMENT WHICH IS APPROXIMATELY 1.0MM BY 1.5MM WAS ALSO RETURNED. THE BREAK IS OBLIQUE. THE REMAINDER OF THE STARDRIVE TIP IS TWISTED APPROXIMATELY 10-15 DEGREES IN THE DIRECTION OF RESISTANCE MET DURING SCREW INSERTION. THE MATERIAL SURFACE AT THE FRACTURE SITE APPEARS HOMOGENEOUS WHEN VIEWED UNDER 5X MAGNIFICATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICE IS ALREADY BROKEN. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AT CQ FOR THE RETURNED DEVICE AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE RETURNED DEVICE (03.130.010 STARDRIVE SCREW DRIVER SHAFT 1.3/1.5 T4 SELF-HOLD) IS AN INSTRUMENT USED IN THE VARIABLE ANGLE LOCKING HAND SYSTEM. RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, FORCE AND TORQUE IS APPLIED TO THE TIP OF THE DRIVER TO TIGHTEN SCREWS TO THE PLATE. IT IS LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO EXCESSIVE FORCE/TORQUE APPLIED TO THE TIP OF THE DRIVER, CAUSING THE TIP TO TWIST AND ULTIMATELY BREAK. 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. 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

    DATE RETURNED TO MANUFACTURER SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, THE SCREW DRIVER SHAFT WAS USED IN SURGERY FOR THE FIRST METACARPAL BONE FRACTURE. WHILE THE SURGEON WAS INSERTING THE CORTEX SCREW USING THE SCREW DRIVER, THE TIP OF THE SCREW DRIVER SHAFT BROKE. THE BROKEN PIECE OF THE SCREW DRIVER SHAFT WAS STUCK TO THE HEAD OF THE CORTEX SCREW. NO BROKEN PIECE WAS LEFT IN THE PATIENT¿S BODY. ACCORDING TO THE SURGEON¿S OPINION, THE TIP OF THE SCREW DRIVER SHAFT MAY HAVE BEEN BROKE DUE TO TOO MUCH FORCE APPLIED DURING SCREWING. NO DELAY IN SURGERY WAS REPORTED. PATIENT OUTCOME WAS REPORTED AS GOOD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: CORTEX SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441415 STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC SCREWDRIVERS HXX SYNTHES MONUMENT 9881569 07611819682962

    Patients

    Seq Age Sex Outcome Treatment
    1