BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTION SLEEVE F/INSERTION INSTR

    MDR report key: 8161853 · Received December 13, 2018

    Report

    Report Number
    2939274-2018-55392
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Report Date
    December 11, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GEA
    UDI-DI
    10886982274441
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. DEVICE HISTORY LOT PART: 03.168.013; LOT: 170413-205; MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 23. APRIL 2018. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY: VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED PROTECTION SLEEVE PERFORMED CONFIRMED THE CONDITION OF POST MANUFACTURING DAMAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. THE DISTAL CANNULATED TIP IS SIGNIFICANTLY DEFORMED. THE TIP OF THE TUBE WALL IS COLLAPSED AND CRUMPLED IN SEVERAL AREAS. THE PROTECTION SLEEVE FOR INSERTION INSTRUMENTS IS A REUSABLE INSTRUMENT IN DEPUY SYNTHES FEMORAL NECK SYSTEM (FNS) WHICH IS INTENDED FOR TEMPORARY FIXATION, CORRECTION OR STABILIZATION OF BONES IN THE FEMORAL NECK AND WITH INDICATIONS FOR FEMORAL NECK FRACTURES. THE PROTECTION SLEEVE ATTACHES TO THE INSERTION HANDLE AND ALLOWS GUIDED DRILLING FOR THE LOCKING SCREW. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. DIMENSIONAL INSPECTION: THE SHAFT OUTSIDE DIAMETER JUST PROXIMAL TO THE DAMAGED TIP MEASURED Ø8.05MM WHICH IS WITHIN SPECIFICATION OF Ø8.1MM +0/-0.1MM. AN ACCURATE MEASUREMENT OF THE INSIDE DIAMETER AT THE DISTAL TIP COULD NOT BE OBTAINED BECAUSE OF THE POST MANUFACTURING DAMAGE. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE DEVICE BECOMING DAMAGED COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE DAMAGE PATTERN SUGGESTS THAT EXCESSIVE PRESSURE WAS ENCOUNTERED WHICH CAUSED THE DISTAL TUBE WALL TO COLLAPSE AND DEFORM. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 THAT ON AN UNKNOWN DATE, THE TIP OF THE PROTECTION SLEEVE FOR FEMORAL NECK SYSTEM (FNS) INSERTION INSTRUMENT WAS DAMAGED AND THE SCREWDRIVER WOULD NOT PASS THROUGH ANYMORE. IT IS UNKNOWN HOW THE ISSUE WAS FOUND. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998297 PROTECTION SLEEVE F/INSERTION INSTR CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY GEA WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.168.013 170413-205 10886982274441

    Patients

    Seq Age Sex Outcome Treatment
    1