BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 7324844 · Received March 8, 2018

    Report

    Report Number
    2939274-2018-50935
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Report Date
    February 8, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982196064
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 357.372 , SYNTHES LOT NUMBER: 5180255 , SUPPLIER LOT NUMBER: 5180255 , RELEASE TO WAREHOUSE DATE: 03-MAR-2006 , SUPPLIER: NA , MANUFACTURING SITE: (B)(4) : NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. THE RETURNED HELICAL BLADE INSERTER (PART: 357.372, LOT: 5180255, MFG: 03-MAR-2006) WAS INSPECTED AND THE COMPLAINT OF BROKEN WAS UNCONFIRMED AS NO BREAKAGE OF DEVICE WAS OBSERVED. HOWEVER, BASED ON THE VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY, IT WAS OBSERVED THAT THE DISTAL CANNULATION GOT NICKED AT ONE OF ITS EDGE LEADING TO SLIGHTLY BENT EDGE AND ROUNDED CANNULATION. ADDITIONALLY, ALIGNMENT INDICATOR WAS STUCK INTO THE INSERTER. LASTLY, THE HANDLE OF THE INSERTER HAS ALL OVER GOUGING. THEREFORE, OVER ALL COMPLAINT CONDITION WAS CONFIRMED. WHETHER THIS COMPLAINT COULD BE REPLICATED IS NOT APPLICABLE AS THE DEVICE WAS RETURNED DAMAGED. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED (BOTH CURRENT AND FROM THE TIME OF MANUFACTURE): TOP-LEVEL DRAWING FOR HELICAL BLADE INSERTER 357_372 (REV. C TO REV. F), GUIDE SHAFT 357_372_1_1(REV. B), ALIGNMENT INDICATOR 357_372_3(REV. D TO REV. E) AND NO DESIGN ISSUES OR DISCREPANCIES WERE NOTED. DIMENSIONAL ANALYSIS PERFORMED AT THE TIP MEASURED THE OUTER DIAMETER AS 8.94 MM (CA 814) THAT FALLS IN SPECIFICATION OF 8.9 MM TO 8.95 MM BASED ON 357_372_1_1 (REV. B). ADDITIONALLY, INSERTER CANNULATION WAS ABLE TO ACCEPT 5.28MM GAGE PIN (G 29) THAT FALLS OUT OF THE SPECIFICATIONS OF 5.3 MM TO 5.4 MM. THE OBTAINED OUT OF SPECIFICATION DIMENSIONS WAS DUE TO POST MANUFACTURING DAMAGE. DIMENSIONAL ANALYSIS WAS NOT ABLE TO BE PERFORMED AT THE STUCK REGION AS THE ALIGNMENT INDICATOR WAS NOT ABLE TO BE REMOVED FROM THE INSERTER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO NCRS, MRRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ALSO, BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT ANY ISSUES WITH MATERIAL OR MATERIAL PROPERTIES CONTRIBUTED TO THE COMPLAINT CONDITION. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS LIKELY THAT THE POSSIBLE MISALIGNMENT DURING INSERTION OR ANY UNINTENDED FORCES ENCOUNTERED BY THE DEVICE SUCH AS BEING DROPPED OFF DURING USAGE COULD HAVE CONTRIBUTED TO THE STUCK AND BENT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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: THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. UNKNOWN WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    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 A HELICAL BLADE COUPLING SCREW AND A HELICAL BLADE INSERTER ARE BROKEN AND BENT. THESE WERE DISCOVERED IN CENTRAL STERILE PROCESSING. NO PATIENT INVOLVEMENT REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166796 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5180255 10886982196064

    Patients

    Seq Age Sex Outcome Treatment
    1