BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAD AIMING ARM/FRN GREATER TROCHANTER

    MDR report key: 12080433 · Received June 28, 2021

    Report

    Report Number
    2939274-2021-03276
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    June 6, 2021
    Report Date
    June 6, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982271075
    PMA / PMN Number
    K172157
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. H3, H4, H6: PART (B)(4), LOT L862674: MANUFACTURING SITE: HAGENDORF. RELEASE TO WAREHOUSE DATE: AUGUST 21, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED ONE OF THE LOCKING CLIPS HAD BROKEN OFF. A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. THE CURRENT AND MANUFACTURED TO DRAWING WAS REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THIS COMPLAINT IS CONFIRMED AS ONE OF THE LOCKING CLIPS HAD BROKEN OFF. NO PHOTOS OR XRAYS WERE RETURNED TO SHOW AN EMBEDDED DEVICE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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) 2021, THE SUPERIOR LOCKING CLIP ON THE FEMORAL RECON NAILS GREATER TROCHANTERIC AIMING ARM BROKE OFF AND WAS NOT ABLE TO LOCK UNKNOWN SUPERIOR RECON SCREW CANNULA INTO AIMING ARM. FRAGMENTS WERE RETAINED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK, SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR (1) RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975604 RAD AIMING ARM/FRN GREATER TROCHANTER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.033.003 L862674 10886982271075

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR UNK - SCREWS: TRAUMA.