BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® COUPLING SCREW

    MDR report key: 8151298 · Received December 11, 2018

    Report

    Report Number
    2939274-2018-55348
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Report Date
    November 20, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWB
    UDI-DI
    10886982193322
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: INITIAL REPORTER IS SYNTHES QUALITY REPRESENTATIVE. DEVICE HISTORY LOT PART NUMBER: 338.31; SYNTHES LOT NUMBER: 5800177. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: 06-JUN-2008. EXPIRATION DATE: N/A. MANUFACTURED BY SYNTHES (B)(4). 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. INVESTIGATION SUMMARY: VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY (CQ) CONFIRMED THE CONDITION OF DEVICE BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. THE DISTAL CANNULATED THREADED TIP HAS SHEARED OFF AT MOST PROXIMAL THREAD. THE DISTAL SHEARED OFF TIP FRAGMENT WAS NOT RETURNED. THE BREAK IS MOSTLY TRANSVERSE BUT WITH ONE JAGGED EDGE. THE BALANCE OF THE DEVICE SHOWS WEAR CONSISTENT WITH USE. DHR REVIEW: THE RETURNED DEVICE WAS MANUFACTURED IN JUNE 2008 AND IS OVER 10 YEARS OLD. 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. DOCUMENT/SPECIFICATION REVIEW: THE DHS/DCS COUPLING SCREW (338.31) IS A REUSABLE INSTRUMENT IN THE DHS ONE-STEP BASIC SET WHICH CAN BE UTILIZED DURING DYNAMIC HIP AND CONDYLAR SCREW (DHS/DCS) PROCEDURES. THE COUPLING SCREW IS INSERTED INTO THE WRENCH (338.302) AND, AFTER SLIDING THE DHS PLATE ONTO THE SHAFT OF THE WRENCH, THE APPROPRIATE LAG SCREW CAN BE SEATED ON THE END OF THE WRENCH AND SECURED USING THE COUPLING SCREW. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. DIMENSIONAL INSPECTION: THE CANNULATION / INSIDE DIAMETER JUST PROXIMAL TO THE BREAK MEASURED Ø2.68MM WHICH IS WITHIN SPECIFICATION OF Ø2.6MM +0.15/-0MM. THE SHAFT OUTSIDE DIAMETER JUST PROXIMAL TO THE BREAK MEASURED Ø3.99MM WHICH IS WITHIN SPECIFICATION OF Ø4.0MM +0.05/-0.03MM PER SHAFT COMPONENT. MATERIAL ANALYSIS: DURING THE DHR REVIEW, THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE RETURNED 10 YEAR OLD REUSABLE CANNULATED INSTRUMENT BREAKING COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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, A COUPLING SCREW WAS FOUND BROKEN DURING A ROUTINE RECEIVING INSPECTION AT THE OWENS & MINOR FIELD STOCK LOCATION FACILITY. THERE WAS NO KNOWN PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DHS®/DCS® COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990953 DHS®/DCS® COUPLING SCREW EXTRACTOR HWB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5800177 10886982193322

    Patients

    Seq Age Sex Outcome Treatment
    1