BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER

    MDR report key: 11102318 · Received December 31, 2020

    Report

    Report Number
    2939274-2020-05818
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    December 5, 2020
    Report Date
    December 5, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982227300
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 01-SEP-2015, EXPIRATION DATE: 31-JUL-2024, PART NUMBER: 456.358S, 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STERILE, LOT NUMBER: 9888320 (STERILE), LOT QUANTITY: (B)(4). THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 456.314.3, LOCK DRIVER TFN, BP55, LOT NUMBER: 7947266, LOT QUANTITY: (B)(4). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INSPECT DIMENSIONAL / FINAL, MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 456.315.2, LOCK 130 BP58, LOT NUMBER: 9861741, LOT QUANTITY: (B)(4). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS ACCEPTANCE SHEET, MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21069, TIALNBRI18.00, BP80, LOT NUMBER: 7989996, LOT QUANTITY: (B)(4). CERTIFIED TEST REPORT WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 17-APR-2015 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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, WHEN IMPLANTING A 10MM/130DEGREE TI CANNULATED TROCHANTERIC FIXATION NAIL 380MM, THE INTERNAL LOCKING MECHANISM WAS ALREADY DAMAGED. THE LOCKING MECHANISM WAS ENGAGED AND BECAUSE OF THAT THE DRILL/HELICAL BLADE COULD NOT GO THOROUGH THE NAIL. THE INTERNAL LOCKING MECHANISM WAS RELEASED IN ORDER TO GET THE HELICAL BLADE. THE FLEXIBLE SCREWDRIVER HAD TO USE TO GET THE INTERNAL LOCKING MECHANISM TO THE RIGHT PLACE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566296 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 456.358S 9888320 10886982227300

    Patients

    Seq Age Sex Outcome Treatment
    1