BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 95MM-STERILE

    MDR report key: 8171775 · Received December 17, 2018

    Report

    Report Number
    2939274-2018-55430
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 25, 2018
    Report Date
    November 26, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982226709
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 456.304S. LOT NUMBER: 7510035. PART MANUFACTURING DATE: 25 OCTOBER 2013. MANUFACTURING SITE: ELMIRA. PART EXPIRATION DATE: 01 SEPTEMBER 2022. NONCONFORMANCE NOTED: N/A. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 7510035 OF TI HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT 7100893 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. DEVICE EVALUATION: INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL AND DAMAGE: VISUAL (APPEARANCE NOT AS EXPECTED). VISUAL INSPECTION: THE RETURNED HELICAL BLADE (456.304S) WAS EXAMINED AND SHOWED SURFACE WEAR AND MINOR DEFORMATION AT THE DISTAL TIP CONSISTENT WITH MISALIGNMENT. FUNCTIONAL TEST:THE HELICAL BLADE WAS ABLE TO BE INSERTED INTO THE PROXIMAL HEAD ELEMENT HOLE OF THE RETURNED NAIL (456.415S) AND THE LOCKING MECHANISM WAS ABLE TO BE ENGAGED AS INTENDED. THE COMPLAINT CONDITION OF MISALIGNMENT WAS UNABLE TO BE REPLICATED. DIMENSIONAL INSPECTION: INSPECTION OF THE RELEVANT FEATURE, DISTAL TIP, WAS UNABLE TO BE COMPLETED DUE TO POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DRAWINGS, REFLECTING THE CURRENT REVISION AND MANUFACTURED REVISIONS, WERE REVIEWED: DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS DAMAGE WAS OBSERVED WHICH IS CONSISTENT WITH A MISALIGNMENT WHILE ATTEMPTING TO INSERT A HELICAL BLADE THROUGH THE NAIL. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER MISALIGNMENTS ARE TYPICALLY SURGICAL TECHNIQUE RELATED AND/OR A RESULT OF PATIENT ANATOMY. THE SYSTEM RISK DOCUMENT WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT ALLEGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 PRODUCT CODE: HWC. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; 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 DURING A HIP SURGERY ON (B)(6) 2018, THE HELICAL BLADE DID NOT INSERT THROUGH THE TROCHANTERIC FIXATION NAIL (TFN) NAIL CONGRUENTLY. THE SURGEON REMOVED THE NAIL AND IMPLANTED ANOTHER NAIL WITH A NEW HELICAL BLADE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008483 11.0MM TI HELICAL BLADE 95MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 456.304S 7510035 10886982226709

    Patients

    Seq Age Sex Outcome Treatment
    1