BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 7921929 · Received October 1, 2018

    Report

    Report Number
    2939274-2018-54002
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    September 1, 2018
    Report Date
    September 5, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982196019
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 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. ADDITIONAL NARRATIVE: DEVICE EVALUATED BY MFR: PART: 357.366; SYNTHES LOT: 5120275; SUPPLIER LOT: N/A; RELEASE TO WAREHOUSE DATE: NOVEMBER 23, 2005; EXPIRATION DATE: N/A; MANUFACTURED BY SYNTHES BRANDYWINE. NO NONCONFORMANCE REPORTS (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. THE INSTRUMENT WAS RECEIVED WITH THE REPORTED CONDITION OF ¿DEVICE INTERACTION (2+ DEVICES) UNABLE TO ASSEMBLE: RM¿. THE FOLLOWING INVESTIGATION FLOW WERE PERFORMED: DAMAGE: VISUAL (APPEARANCE NOT AS EXPECTED). VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) OBSERVED THAT INSTRUMENT IS WORN, HOWEVER NO DAMAGE WAS OBSERVED. PLEASE NOTE THAT BOTH INSTRUMENTS WERE RETURNED IN A SEPARATED STATE. A FUNCTIONAL TEST WAS PERFORMED WITH THE RETURNED BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS AND THE SLEEVE WAS ABLE TO BE SEPARATED EASILY FROM THE AIMING ARM. THIS WAS REPEATED FIVE TIMES, AND IN EACH INSTANCE NO ISSUE WAS NOTED. THE GIVEN COMPLAINT CONDITION DOES NOT AGREE WITH THE RETURNED DEVICE CONDITION, AS THE COMPLAINT COULD NOT BE REPLICATED WITH THE RETURNED DEVICES AND THEREFORE IS UNCONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS NO ISSUE WAS NOTED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES 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. CORRECTED DATA: INITIAL REPORTER NAME AND ADDRESS, INITIAL REPORTER HEALTH PROFESSIONAL, INITIAL REPORTER OCCUPATION. 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 · 0

    EVENT OCCURRED DURING THE TITANIUM TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT ID AND WEIGHT WERE NOT PROVIDED FOR REPORTING. DATE OF EVENT IS AN UNKNOWN DATE IN (B)(6) 2018. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. REPORTER IS SYNTHES SALES CONSULTANT. THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 AN UNKNOWN DATE IN (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, THE BLADE GUIDE SLEEVE FOR A TROCHANTERIC FIXATION NAILS WAS STUCK IN THE 130 DEGREE AIMING ARM FOR TROCHANTERIC FIXATION NAILS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762830 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5120275 10886982196019

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR