BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIPOLYAXIAL SCREWDRIVER

    MDR report key: 9828807 · Received March 13, 2020

    Report

    Report Number
    1526439-2020-00703
    Event Type
    Injury
    Date Received
    March 13, 2020
    Date of Event
    February 17, 2020
    Report Date
    February 17, 2020
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HXX
    UDI-DI
    10705034221298
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. H10 ADDITIONAL NARRATIVE: H3, H4, H6: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR MINIPOLYAXIAL SCREWDRIVER WAS CONDUCTED IDENTIFYING THAT LOT NUMBER KM874336 WAS RELEASED IN A SINGLE BATCH. BATCH1: LOT RELEASED ON MAY 17, 2019 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY (CQ) SHOWS DEVICE BROKE AT THE DISTAL TIP (BROKEN TIP NOT RETURNED). THE BREAK IS JAGGED AND OBLIQUE. NO NEW ISSUES WERE IDENTIFIED. A DEVICE FAILURE WAS IDENTIFIED. DIMENSIONAL INSPECTION: Ø DISTAL TIP: CONFORMING DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DOCUMENTS WERE REVIEWED AS PART OF THIS INVESTIGATION: ASSEMBLY MOUNTAINEER POLYAXIAL SCREWDRIVER. HEX SHAFT, MOUNTAINEER POLYAXIAL SCREWDRIVER. BASED ON THE REVIEW OF THE ABOVE DRAWINGS, NO DESIGN ISSUES CONTRIBUTING TO RELEVANT COMPLAINT CONDITION WERE IDENTIFIED. CONCLUSION: NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN, MOST LIKELY EXCESSIVE FORCE WAS USED DURING INSERTION RESULTING IN THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. (B)(4). 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A POSTERIOR FUSION OF THE C2-T8 TREATING A DROPPED HEAD, THE TIP OF THE SCREWDRIVER BROKE OFF WHILE INSERTING THE IMPLANT. IT SEEMED THAT THE BONE HAD BECOME ROBUST DUE TO OSSIFICATION. WITHOUT REMOVING THE FRAGMENT, THE SURGEON WAS ABLE TO DEPLOY A ROD AND COMPLETED THE PROCEDURE WITHOUT SURGICAL DELAY. CONCOMITANT DEVICE: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE MINIPOLYAXIAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292590 MINIPOLYAXIAL SCREWDRIVER SCREWDRIVERS HXX DEPUY SPINE INC 288304000 KM874336 10705034221298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN SCREWS