BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM OSTEOTOME ANGLED

    MDR report key: 9962361 · Received April 15, 2020

    Report

    Report Number
    1526439-2020-00854
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Report Date
    March 20, 2020
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWM
    UDI-DI
    10705034220536
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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: UPDATED DATA-H4. 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 REVIEW OF THE RECEIVING INSPECTION (RI) FOR 8MM OSTEOTOME ANGLED WAS CONDUCTED IDENTIFYING THAT LOT NUMBER PG295782 WAS RELEASED IN A SINGLE BATCH. BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON 13-AUG-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: THE 8MM OSREOTOME ANGLED (P/N: 288205053, LOT #: PG295782) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DISTAL TIP OF THE DEVICE WAS DEFORMED. THERE WERE SCRATCHES ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. 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 WITHIN THE SPECIFICATION. THE OUTER DIAMETER OF THE DISTAL TIP WAS MEASURED TO BE WITHIN THE SPECIFICATION. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED 8 MM OSTEOTOME, ANGLED. 8 MM OSTEOTOME SHAFT, ANGLED. COMPLAINT CONFIRMED? NO, THE DEVICE RECEIVED WAS NOT BROKEN. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS UN-CONFIRMED FOR THE 8MM OSREOTOME ANGLED (P/N: 288205053, LOT #: PG295782). 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 THE 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 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 (B)(6) 2020 THE 8MM OSTEOTOME ANGLED WAS FOUND TO BE BROKEN DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 8MM OSTEOTOME ANGLED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429515 8MM OSTEOTOME ANGLED OSTEOTOME HWM DEPUY SPINE INC 288205053 PG295782 10705034220536

    Patients

    Seq Age Sex Outcome Treatment
    1