BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15

    MDR report key: 7393083 · Received April 3, 2018

    Report

    Report Number
    2939274-2018-51413
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 7, 2018
    Report Date
    April 9, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982077523
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 03.240.002, SYNTHES LOT # 6120824 , SUPPLIER LOT # 6120824 : RELEASE TO WAREHOUSE DATE: 09-JUL-2009 , MANUFACTURING LOCATION: SUPPLIER - UNIVERSAL PUNCH: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. VISUAL INSPECTION CONFIRMED THE REPORTED COMPLAINT CONDITION. THE DISTAL TIP IS WORN AND ALSO SIGNIFICANTLY TWISTED IN THE DIRECTION OF RESISTANCE MET DURING SCREW INSERTION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) VIA FUNCTIONAL TEST IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. THE RETURNED CANNULATED SCREWDRIVER SHAFT WAS MANUFACTURED IN JULY 2009 AND IS OVER 8 YEARS OLD. THE MATERIAL AND RELEVANT MATERIAL PROPERTIES WERE DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR. RELEVANT DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE 03.240.002 T15 CANNULATED STARDRIVE SCREWDRIVER SHAFT IS A REUSABLE INSTRUMENT ROUTINELY USED IN THE 3.7MM CANNULATED LOCKING AND CONICAL SCREWS. A DIMENSIONAL INSPECTION OF THE T15 STARDRIVE OUTER GEOMETRY COULD NOT BE ACCURATELY OBTAINED AT CQ DUE TO THE POST MANUFACTURING DAMAGE (TWISTED). THE INSIDE DIAMETER AT THE DISTAL TWISTED TIP MEASURED AT CQ WHICH IS WITHIN SPECIFICATION PER RELEVANT DRAWING. THE MOST LIKELY CAUSE FOR THIS COMPLAINT IS CUMULATIVE WEAR AND OVER TORQUEING OF THE RETURNED 8+ YEAR OLD SCREWDRIVER SHAFT UNDER POWER DURING ATTEMPTED SCREW INSERTION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT PROXIMAL HUMERUS ON (B)(6) 2018, THREE (3) SEPARATE CANNULATED STARDRIVE SCREWDRIVER SHAFTS BECAME TWISTED AND WOULD NOT PROPERLY SEAT IN THE SCREW RECESS. SURGERY WAS COMPLETED WITH NO DELAY. PATIENT OUTCOME REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER SHAFT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237112 CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15 SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6120824 10886982077523

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR