BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DRILL SLEEVE 3.5 F/DRILL BIT 2.8

    MDR report key: 9792983 · Received March 5, 2020

    Report

    Report Number
    2939274-2020-01136
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Report Date
    February 10, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982187840
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. INVESTIGATION SUMMARY: INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE LCP DRILL SLEEVE 3.5 F/DRILL BIT Ø2.8 (PART #: 312.648, LOT #: 4913618) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE COMPLAINT DEVICE HAD NO DEFECTS. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS NOT PERFORMED WITH THE COMPLAINT DEVICE SINCE THE APPLICABLE MATING COMPONENT(S) WERE NOT RETURNED. DIMENSIONAL INSPECTION: REFERENCED DRAWING SPECIFIED DIMENSIONS: DISTAL SHAFT INNER DIAMETER MEASURED DIMENSIONS: DISTAL SHAFT INNER DIAMETER = CONFORMING MEASUREMENT DEVICE: GP29. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED: - LCP DRILL SLEEVE 3.5 F/DRILL BIT Ø2.8: 312_648 REV N (CURRENT) AND REV J (MANUFACTURED) NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? NO. INVESTIGATION CONCLUSION: THIS COMPLAINT WAS NOT CONFIRMED AS THE COMPLAINT CONDITION COULD NOT BE REPLICATED DUE TO NOT RECEIVING APPLICABLE MATING DEVICE(S). ADDITIONALLY, NO DEFECTS WERE FOUND ON THE DEVICE. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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 HISTORY LOT: PART #: 312.648, SYNTHES LOT NUMBER: 4913618, MANUFACTURING SITE: SYNTHES BRANDYWINE , RELEASE TO WAREHOUSE DATE: JAN 20, 2005. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. H10 ADDITIONAL NARRATIVE: D10: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CUSTOMER RETAINING THE DEVICE. 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 EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS COMPANY REPRESENTATIVE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON AN UNKNOWN DATE A THREADED DRILL GUIDE WAS NOT ABLE TO BE SCREWED ON THE PLATE WITH A SCREWDRIVER AND WAS NOT ABLE TO BE CORRECTLY THREADED ON THE PLATE. NO SURGICAL DELAY WAS REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN); UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN); UNKNOWN, SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 4 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255049 LCP DRILL SLEEVE 3.5 F/DRILL BIT 2.8 GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 312.648 4913618 10886982187840

    Patients

    Seq Age Sex Outcome Treatment
    1 2.8MM THREADED DRILL GUIDE| UNK - PLATES| UNK - SCREWDRIVERS| UNK - SCREWS: TRAUMA