BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREWDRIVER BODY

    MDR report key: 9297494 · Received November 8, 2019

    Report

    Report Number
    1818910-2019-115300
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 16, 2019
    Report Date
    October 16, 2019
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    HXX
    UDI-DI
    10603295116585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED REPORTED EVENT. ROOT CAUSE AND CORRECTIVE ACTION ARE DOCUMENTED IN THE CAPA SYSTEM. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. THE COMPLAINT SAMPLE CONSISTED OF (1) 230792003 LOCKING SCREWDRIVER BODY. EXAMINATION OF THE RETURNED LOCKING SCREWDRIVER BODY CONFIRMED TWO OF THE FOUR TABS HAVE BROKEN OFF. PREVIOUS INVESTIGATIONS IDENTIFIED A TREND FOR THE TEETH BREAKING. A HEALTH HAZARD EVALUATION MEETING WAS CONDUCTED ON JULY 2, 2013 AND IDENTIFIED A POTENTIAL HARM, AS DOCUMENTED IN DVA-108162-HHE VIA ECO 437762, WHICH WAS COMPLETED ON SEPTEMBER 25, 2013. THE ISSUE AND HARM WERE FORWARDED TO THE QUALITY REVIEW BOARD VIA DVA-108162-QRB ON JULY 15, 2013, AND IT WAS DETERMINED THAT A FIELD ACTION WAS NOT NECESSARY DUE TO THE LOW OCCURRENCE RATE. MDD CAPA-001649 WAS INITIATED ON JULY 19, 2013 TO DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS NEEDED. A SALES MAIL WAS ISSUED TO THE US SALES FORCE ON 10/01/2013 TITLED "LOCKING SCREWDRIVER TECHNIQUE REMINDER" TO REINFORCE THE PROPER USE OF THE DRIVER (E.G. KEEPING THE DRIVER IN AXIAL ALIGNMENT WITH THE SCREW AND USING THE DRIVER SLEEVE). THESE ITEMS ARE ALREADY CONTAINED IN THE SURGICAL TECHNIQUE. CAPA-001649 WAS CLOSED ON MAY 9, 2016, IDENTIFYING THE ROOT CAUSE TO BE INADEQUATE DESIGN. THE ACTIONS IMPLEMENTED AS A RESULT OF THIS CAPA HAVE ADDRESSED THE ROOT CAUSE OF INADEQUATE DESIGN. THE REDESIGN OF THE DELTA EXTEND SCREWDRIVER GUIDE ENSURE THAT THE SCREWS ARE CAPTURED PROPERLY AND TORQUED "ON-AXIS," THUS PREVENTING OVERLOADING OF THE TEETH IN THE SCREWDRIVER, WHICH COULD RESULT IN THE FRACTURING OF THE TEETH AS SEEN IN THE INITIAL COMPLAINTS. THE MATERIAL CHANGE FROM 455 STAINLESS TO 465 STAINLESS RESULTED IN A MORE RESILIENT DEVICE AND ONE IN WHICH THE FAILURE MODE CHANGED FROM FRACTURE (OF THE TEETH) TO DEFORMATION. (B)(4) WAS RELEASED ON DECEMBER 11, 2015 TO CHANGE THE MATERIAL FROM 455 STAINLESS TO 465 STAINLESS RESULTED IN A MORE RESILIENT DEVICE AND ONE IN WHICH THE FAILURE MODE CHANGED FROM FRACTURE (OF THE TEETH) TO DEFORMATION. THE CURRENT COMPLAINT SAMPLE DEVICE WAS MANUFACTURED PRIOR TO THE RELEASE OF THE NEW DESIGN. COMPLAINT TRENDING WILL BE CONDUCTED BY POST MARKET SURVEILLANCE THROUGH SEP-419. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. 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

    PRODUCT COMPLAINT # (B)(4). 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 THAT THE SCREW TIP WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094177 LOCKING SCREWDRIVER BODY EXTREMITY INSTRUMENTS : SCREWDRIVERS HXX DEPUY FRANCE SAS - 3003895575 2307-93-000 5209164 10603295116585

    Patients

    Seq Age Sex Outcome Treatment
    1