BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL SPACER HANDLE

    MDR report key: 6036148 · Received October 18, 2016

    Report

    Report Number
    1719045-2016-10760
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Report Date
    September 26, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT REPORTED. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. THERAPY DATE OF CONCOMITANT DEVICE IS UNKNOWN. SERVICE AND REPAIR EVALUATION WAS ATTEMPTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART # 389.151 WITH LOT # 7212998 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS MAR 26, 2013. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 3893.151, LOT# 7212998, RELEASE TO WAREHOUSE DATE: MAR 26, 2013, SUPPLIER: (B)(4). NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE 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

    THE DEVICE WAS DISCOVERED BROKEN ON (B)(6) 2016, BUT IT IS UNKNOWN WHEN IT BROKE. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE TIP BROKE OFF AND WAS STUCK INSIDE A TRIAL IMPLANT. THE REPAIR TECHNICIAN REPORTED THE TIP OF THE SPINDLE ASSEMBLY BROKE OFF STUCK IN THE TRIAL IMPLANT. TIP 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. INITIALLY REPORTED AS (B)(6) 2016, BUT SHOULD HAVE BEEN (B)(6) 2016 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. IT WAS REPORTED THAT THE THREADED TIP OF A TRIAL SPACER HANDLE (389.151 LOT 7212998) WAS FOUND TO BE BROKEN AND LODGED IN A SYNFIX TRIAL IMPLANT (03.802.005 LOT 2379236) PRIOR TO A PROCEDURE; NO PATIENT INVOLVEMENT. THE RETURNED INSTRUMENT WAS RETURNED TO SERVICE AND REPAIR WHERE THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AND THE DEVICE WAS DEEMED UNREPAIRABLE. THE DEVICE WAS FORWARDED TO CUSTOMER QUALITY FOR INVESTIGATION AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE THREADED TIP OF THE SPINDLE WAS CONFIRMED TO BE BROKEN. THE THREADED REGION OF THE RETURNED DEVICE WAS MEASURED TO BE 3.6MM (CALIPERS CA94P) AND IS MANUFACTURED TO BE 6.25MM; AS SUCH THE DISTAL 2.65MM OF THE TIP IS MISSING AND WAS FOUND TO BE LODGED IN THE RETURNED TRIAL IMPLANT. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS SURGICAL TECHNIQUE AT THE TIME OF FAILURE WAS UNKNOWN. THIS FAILURE MODE IS TYPICALLY ASSOCIATED WITH IMPACTION WHEN THE SPINDLE IS NOT FULLY THREADED INTO THE TRIAL AND/OR OFF-AXIS LOADING. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. 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

    SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT THE TIP OF THE TRIAL SPACER HANDLE BROKE OFF AND IS STUCK INSIDE THE SYNFIX TRIAL IMPLANT. ISSUE WAS DISCOVERED DURING THE ROUTINE SERVICE AND REPAIR ACTIVITIES OF THE EVALUATION SET, NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: SYNFIX-LR TIRAL IMPLANT PART # 03.802.005, LOT # 2379236, QUANTITY 1. THIS REPORT IS FOR ONE (1) TRIAL SPACE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE ISSUE WAS DISCOVERED PRIOR TO AN UNKNOWN PROCEDURE ON (B)(6) 2016. THE DEVICE WAS NOT USED DURING SURGERY; THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688489 TRIAL SPACER HANDLE FORCEPS HTD SYNTHES MONUMENT 7212998

    Patients

    Seq Age Sex Outcome Treatment
    1 PART # 03.802.005, LOT # 2379236, QUANTITY 1