BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE/SCREW EXTRACTOR

    MDR report key: 9812483 · Received March 10, 2020

    Report

    Report Number
    2939274-2020-01195
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Report Date
    February 13, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982070463
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6 INVESTIGATION SUMMARY. VISUAL INSPECTION: THE HELICAL BLADE/SVREW EXTRACTOR (P/N: (B)(4), LOT #: 4L24681) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DISTAL SHAFT OF THE EXTRACTOR AT THE MOST PROXIMAL THREADS OF THE THREADED FEATURE WAS BROKEN AND THE BROKEN PART WAS LODGED INSIDE THE RETURNED HELICAL BLADE (P/N: (B)(4), LOT #: H760399). THERE WERE SCRATCHES ON THE DEVICE CONSISTENT WITH THE DEVICE USE BUT HAVE NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: THE DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE OUTER DIAMETER OF THE SHAFT WAS MEASURED TO BE 4.98 MM (CA 215P). THIS IS WITHIN THE SPECIFICATION OF 5.0 MM +0/-0.05 MM, AS PER THE DRAWING. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED EXTRACTION INSTRUMENT FOR HEAD ELEMENT. SHAFT FOR EXTRACTION INSTRUMENT. COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED WAS BROKEN. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE HELICAL BLADE/SVREW EXTRACTOR (P/N: (B)(4), LOT #: 4L24681). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY: PART: 03.037.030. LOT: 4L24681. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: (B)(6) 2019 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMITIES WERE IDENTIFIED. H11 CORRECTED DATA. D10: 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: SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE TIP OF A HELICAL BLADE/ SCREW EXTRACTOR WAS BROKE. STERILE PROCESSING STAFF WERE ATTEMPTING TO UNCOUPLE A HELICAL BLADE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273548 HELICAL BLADE/SCREW EXTRACTOR ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.030 4L24681 10886982070463

    Patients

    Seq Age Sex Outcome Treatment
    1 HELICAL BLADE/SCREW EXTRACTOR.| UNK - NAIL HEAD ELEMENTS: HELICAL BLADE.