BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 100MM-STERILE

    MDR report key: 11673462 · Received April 15, 2021

    Report

    Report Number
    2939274-2021-01857
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 18, 2021
    Report Date
    March 18, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982226723
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). 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. H3, H6: INVESTIGATION SUMMARY: INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE 11.0MM TI HELICAL BLADE 100MM-STERILE (PART#: 456.305S, LOT#: 9832862) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED ONLY SCRATCHES. NO OTHER DEFECT WAS OBSERVED FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED WITH THE COMPLAINT DEVICE BY INSERTING IT INSIDE THE TRANSVERSAL HOLE OF THE OTHER RETURNED TFNA NAIL (PART#: 456.328S; LOT#: 7944429). THE HELICAL BLADE WAS ABLE TO SLIDE THROUGH THE HOLE WITHOUT INTERFERENCE OR ISSUE. NO OTHER ASSESSMENT WAS COMPLETED AS THE OTHER COMPONENTS WERE NOT RETURNED. THE COMPLAINT CAN NOT BE REPLICATED WITH THE RETURNED DEVICE. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THE COMPLAINT WAS NOT CONFIRMED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS UNCONFIRMED AS NO DEFECT THAT COULD AFFECT THE FUNCTIONALITY OF THE DEVICE WAS FOUND. THE SCRATCHES OBSERVED ON THE SURFACE MAY POTENTIALLY DUE TO THE PROCEDURE THAT THE SURGEON WAS PERFORMING AND DO NOT IMPACT THE FUNCTIONALITY OF THE DEVICE. NO ROOT CAUSE COULD DEFINITELY 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 PREVENTIVE 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 LOT: PART NUMBER: 456.305S, LOT NUMBER: 7973916, PART MANUFACTURE DATE: JAN 12, 2015, MANUFACTURING LOCATION: ELMIRA, PART EXPIRATION DATE: NOV 30, 2023, NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11.0MM TI HELICAL BLADE 100MM-STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL, AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCE NOTED. THIS RAW MATERIAL 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. PART NUMBER: 456.305S, LOT NUMBER: 9832862, PART MANUFACTURE DATE: JUL 15, 2015, MANUFACTURING LOCATION: ELMIRA, PART EXPIRATION DATE: JUN 30, 2024, NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11.0MM TI HELICAL BLADE 100MM-STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL, AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCE NOTED. THIS RAW MATERIAL 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. 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 PROCODE: HWC. 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 (B)(6) 2021 DURING AN INTRAMEDULLARY FEMORAL NAIL PROCEDURE, THE TI HELICAL BLADE AND THE TI TROCHANTERIC FIXATION NAIL WERE STUCK TOGETHER. UPON INSERTION OF THE TI HELICAL BLADE THROUGH THE TI TROCHANTERIC FIXATION NAIL, IT COLLIDED WITH THE INTERNAL LOCKING MECHANISM. BOTH IMPLANTS WERE REMOVED AND REPLACED SUCCESSFULLY USING BACK UP DEVICES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 100MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573704 11.0MM TI HELICAL BLADE 100MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 456.305S 9832862 10886982226723

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR 11/130 DG TI CAN TROCH FIXATN NL 235-S.