BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDING MECHANISM

    MDR report key: 8135602 · Received December 5, 2018

    Report

    Report Number
    2939274-2018-55304
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Report Date
    November 16, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982188779
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. DEVICE HISTORY LOT PART: 314.291, LOT: 11-7600, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 08. AUG. 2011. 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, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. 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. SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE SLIDING MECHANISM WAS NOT WORKING. THE REPAIR TECHNICIAN REPORTED THE HANDLE WAS BROKEN OFF AT THE SCREW. HANDLE CRACKED/BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. THE SLIDING MECHANISM (PART NUMBER 314.291, LOT NUMBER 11-7600) WAS RETURNED TO US CUSTOMER QUALITY. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE BLACK POLYAMIDE HANDLE WAS BROKEN AT THE DISTAL ATTACHMENT SCREW (BOTTOM MOST). THE TWO SCREWS WHICH ARE HOLDING THE HANDLE ARE STILL IN PLACE, REMAINING WITHIN THE INSTRUMENT. IN ADDITION, THE KNOB APPEARED TO BE DULL, A FEW SCRATCHES WERE OBSERVED ON THE ROD AND DISCOLORATION WAS NOTED AROUND THE SPRING ASSEMBLY. THESE SIGNS OF WEAR ARE CONSISTENT WITH THE AGE OF THE DEVICE (7+ YEARS) AND DO NOT AFFECT THE PRODUCT FUNCTIONALITY. NO NEW ISSUES WERE IDENTIFIED DURING INVESTIGATION. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS MORE LIKELY THAT UNINTENDED EXCESSIVE FORCES SUCH AS DEVICE BEING DROPPED DURING USAGE/HANDLING CONTRIBUTED TO THIS COMPLAINT CONDITION. FURTHERMORE, THE COMPLAINT DESCRIPTION STATES THAT THE DEVICE WAS DROPPED AND IT BROKE. THEREFORE, BASED ON COMPLAINT DESCRIPTION AND RELEVANT DAMAGES NOTED ON THE SLIDING MECHANISM, THE OVERALL COMPLAINT CONDITION IS CONFIRMED. DOCUMENT/SPECIFICATION REVIEW FOLLOWING RELEVANT DRAWINGS, REFLECTING THE CURRENT REVISION AND THE MANUFACTURED REVISION OF THE DEVICE (TOP LEVEL) AND THE HANDLE (SUB-COMPONENT) WERE REVIEWED. 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. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. DIMENSIONAL ANALYSIS WAS COMPLETED. THICKNESS OF HANDLE ADJACENT TO DISTAL SCREW ATTACHMENT MEASURED 20.03 MM. THIS IS WITHIN SPECIFICATION OF 20 +/- 0.2 MM . DIMENSIONAL ANALYSIS AROUND OTHER PARTS OF THE BROKEN HANDLE COULD NOT BE MEASURED ACCURATELY DUE TO POST MANUFACTURING DAMAGES. CONCLUSION: THE COMPLAINT DESCRIPTION STATES THAT THE DEVICE WAS DROPPED AND IT BROKE. THEREFORE, BASED ON COMPLAINT DESCRIPTION AND RELEVANT DAMAGES NOTED ON THE SLIDING MECHANISM, THE OVERALL COMPLAINT CONDITION IS CONFIRMED. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS MORE LIKELY THAT UNINTENDED EXCESSIVE FORCES SUCH AS DEVICE BEING DROPPED DURING USAGE/HANDLING CONTRIBUTED TO THIS COMPLAINT CONDITION. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. OCCUPATION: SYNTHES SALES REPRESENTATIVE. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SLIDING MECHANISM DROPPED AND BROKE. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED OR IF THERE WAS A PATIENT OR PROCEDURE INVOLVEMENT. THIS COMPLAINTS INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975743 SLIDING MECHANISM FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11-7600 10886982188779

    Patients

    Seq Age Sex Outcome Treatment
    1