BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8

    MDR report key: 7153821 · Received December 29, 2017

    Report

    Report Number
    2939274-2017-50485
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 1, 2017
    Manufacturer
    WRIGHTS LANE: SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982077042
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT IDENTIFIER: (B)(6). CONCOMITANT DEVICES, BRAND NAME, DATE RETURNED TO MANUFACTURER, HOSPITAL CONTACT, DHR REVIEW WAS COMPLETED. PART NO.: 03.226.004, LOT NO.: 2213646, MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: 15.SEP.2006. 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 CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. THE CANNULATED STARDRIVE SCREWDRIVER SHAFT T8 (03.226.004) IS A COMPONENT OF THE 2.4/3.0MM HEADLESS COMPRESSION SCREW INSTRUMENT SET (01.226.022) AND IT UTILIZED FOR SCREW INSERTION. HEADLESS COMPRESSION SCREWS ARE UTILIZED FOR FIXATION OF SMALL BONES AND SMALL BONE FRAGMENTS. THE RETURNED INSTRUMENT WAS INSPECTED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE TIP WAS FOUND TO BE BROKEN AND MISSING A PORTION OF THE TIP. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE DURING REMOVAL. THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED DUE TO POST-MANUFACTURING DAMAGE. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE): TOP-LEVEL. THE 1.18MM CANNULATION IS NECESSARY TO PROVIDE PRECISE SCREW PLACEMENT VIA A 1.1MM GUIDE WIRE AND THE T8 STARDRIVE GEOMETRY AT THE TIP IS NECESSARY TO ENGAGE THE T8 STARDRIVE RECESS IN 2.4MM AND 3.0MM SELF-DRILLING, SELF-TAPPING CANNULATED HEADLESS COMPRESSION SCREWS. TO ACCOUNT FOR THIS, THE SCREWDRIVER SHAFT IS MANUFACTURED FROM HARDENED AND TEMPERED X15TN STAINLESS STEEL, A COMMONLY USED HIGH STRENGTH, CORROSION RESISTANT MATERIAL COMMON IN INSTRUMENT APPLICATIONS. THUS, THE DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE AND THE COMPLAINT CONDITION IS LIKELY NOT THE RESULT OF A DESIGN DEFICIENCY. NO DIMENSIONAL ANALYSIS IS APPLICABLE AS THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED. A DEVICE HISTORY REVIEW, INCLUDING MATERIAL REVIEW, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. %%THE DEVICE WAS REMOVED FROM THE PATIENT INTRAOPERATIVELY. PHYSICAL PRODUCT INVESTIGATION IS NOT YET COMPLETED; NO CONCLUSION COULD BE DRAWN. DEVICE HISTORY RECORD: MANUFACTURING LOCATION: (B)(4). NO NON-CONFORMANCE REPORTS 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. 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

    CONCOMITANT DEVICES REPORTED: SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS TIGHTENING A SCREW DURING SURGERY AND THE END OF THE T8 SCREWDRIVER BROKE. THE BROKEN FRAGMENTS WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION AND NO PARTS WERE LEFT IN THE PATIENT. AS THE SURGEON WAS TIGHTENING THE SCREW BY HAND, THE SCREW WAS NOT DAMAGED AND IS IN THE PATIENT AT THIS TIME. THE PATIENT OUTCOME WAS GOOD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES ONE (1) PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934582 CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8 SCREWDRIVERS HXX WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 2213646 10886982077042

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR