BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT SLEEVE 13 F/RETROGR-APPROACH

    MDR report key: 7649997 · Received June 29, 2018

    Report

    Report Number
    2939274-2018-52678
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Report Date
    June 28, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    1088698219379
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THERAPY DATE OF CONCOMITANT DEVICE IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NUMBER: 357.127; SYNTHES LOT NUMBER: 5791407; SUPPLIER LOT NUMBER: N/A; RELEASE TO WAREHOUSE DATE: 28-MAY-2008; EXPIRATION DATE: N/A; MANUFACTURED BY SYNTHES (B)(4). NO 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: IT WAS REPORTED DURING A RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) PROCEDURE ON AN UNKNOWN DATE, THE DRILL GUIDE WAS WORN OUT AND THE DRILL BIT WAS STARTING TO STICK WHEN PASSING THROUGH IT. THE SURGEON DID COMPLAIN ABOUT IT NOT PASSING THROUGH SMOOTHLY AS IT SHOULD. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL TIME DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANTICIPATED. THE INSTRUMENT WAS RECEIVED WITH THE REPORTED CONDITION OF ¿UNABLE TO ASSEMBLE: NRM¿ AT CUSTOMER QUALITY, THE RETURNED INSTRUMENT WAS INSPECTED AND THE COMPLAINT WAS CONFIRMED. THE FOLLOWING INVESTIGATION FLOW WAS PERFORMED: DAMAGE: VISUAL (APPEARANCE NOT AS EXPECTED): THE RETURNED INSTRUMENT WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS LOOKING INSIDE THE SHAFT SHOWS SIGNIFICANT DEFORMATION MARKS AN INDICATION THE DEVICE WAS HEAVILY USED DURING ITS 10-YEAR LIFESPAN. THE BALANCE OF THE DEVICE IS IN FAIR CONDITION WITH SIGNS OF WEAR AND TEAR. THE RECEIVED CONDITION AGREES WITH THE COMPLAINT DESCRIPTION. A DEVICE HISTORY REVIEW, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED (BOTH CURRENT AND FROM THE TIME OF MANUFACTURE): TOP-LEVEL DRAWING 357_127 WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. DIMENSIONAL INSPECTION WAS PERFORMED AS BELOW: DRAWING: 357_127_2; FEATURE SPECIFICATIONS PER DRAWING: INNER SHAFT Ø13.2 + .1MM/-.05MM; CALIPERS (CA215P): Ø 13.20 MM; GAUGE PIN (GP29): MAX OF Ø 13.2MM COULD BE INSERTED THROUGH THE SHAFT. THE MEASURED DIMENSIONS WERE FOUND TO BE WITHIN THE GIVEN SPECIFICATIONS PER 357_127_2. THE CAUSE FOR THE COMPLAINT IS MOST LIKELY ASSOCIATED WITH THE APPLICATION OF ROUGH HANDLING DURING THE LIFESPAN OF THE DEVICE CAUSING THE DEFORMATIONS WITHIN THE SHAFT CAUSING IT TO STICK WHEN A DRILL BIT IS INSERTED. 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. 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 DURING A RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) PROCEDURE ON AN UNKNOWN DATE, THE DRILL GUIDE WAS WORN OUT AND THE DRILL BIT WAS STARTING TO STICK WHEN PASSING THROUGH IT. THE SURGEON DID COMPLAIN ABOUT IT NOT PASSING THROUGH SMOOTHLY AS IT SHOULD. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL TIME DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANTICIPATED. CONCOMITANT DEVICE REPORTED: CANNULATED DRILL BIT (PART# 351.27, LOT# UNKNOWN, QTY 1). THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492399 PROTECT SLEEVE 13 F/RETROGR-APPROACH GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5791407 1088698219379

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR