BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER/EXTRACTOR FOR CHILD & ADOLESCENT OSTEOTOMY PLATES

    MDR report key: 9882469 · Received March 26, 2020

    Report

    Report Number
    2939274-2020-01517
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 4, 2020
    Report Date
    March 4, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWB
    UDI-DI
    10886982192745
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. H3, H4, H6: PART NUMBER: 332.353; SYNTHES LOT NUMBER: 7930179; SUPPLIER LOT NUMBER: N/A; RELEASE TO WAREHOUSE DATE: 22JUN2015; EXPIRATION DATE: N/A; MANUFACTURED BY SYNTHES JENNERSVILLE. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE INSERTER/EXTRACTOR FOR CHILD & ADOLESCENT OSTEOTOMY PLATES (P/N: 332.353, LOT NUMBER: 7930179) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE BOLT COMPONENTS ARE JAMMED AND COULD NOT BE LOOSENED. THERE WAS NO EVIDENCE OF BREAKAGE. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED WITH THE COMPLAINT DEVICE. THE BOLT COMPONENTS ARE JAMMED AND UNABLE TO LOOSEN. THE CONDITION CAN BE REPLICATED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE NATURE OF THE COMPLAINT CONDITION. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE BOLT COMPONENTS ARE JAMMED AND COULD NOT BE LOOSENED. THERE WAS NO EVIDENCE OF BREAKAGE. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE HAS BEEN 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 ON (B)(6) 2020, IT WAS NOTICED THAT BOTH SCREWS IN THE TWO (2) INSERTER/EXTRACTOR FOR CHILD HIP PLATE WERE BOUND OR CROSS-THREADED MAKING THEM UNUSABLE. THE SALES CONSULTANT ATTEMPTED TO UNSCREW THE ONE IN THE INFANT INSERTER/EXTRACTOR, BUT THE SCREW HEAD SNAPPED OFF. THIS DID NOT IMPACT A SURGERY, AS THE SALES CONSULTANT WAS CHECKING THE SET BEFOREHAND. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) INSERTER/EXTRACTOR FOR CHILD & ADOLESCENT OSTEOTOMY PLATES. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346259 INSERTER/EXTRACTOR FOR CHILD & ADOLESCENT OSTEOTOMY PLATES EXTRACTOR HWB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 332.353 7930179 10886982192745

    Patients

    Seq Age Sex Outcome Treatment
    1