BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAGBEETLE FORCEPS 125MM

    MDR report key: 6590483 · Received May 25, 2017

    Report

    Report Number
    9680938-2017-10118
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Report Date
    April 27, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    UDI-DI
    1088698220203
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 398.96 WITH LOT NUMBER(S) T955386 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS DECEMBER 03, 2010. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    SERVICE EVALUATION: THE CUSTOMER REPORTED THAT ONE OF THE POINTS BROKE OFF THE INSTRUMENT. THE REPAIR TECHNICIAN REPORTED THE ONE OF THE POINTS OF THE FORCEPS WAS BROKEN OFF AND MISSING. 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. DHR REVIEW: MANUFACTURING DATE: 01-DEC-2010. REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. ALL 50 PARTS OF THE LOT WERE CHECKED 100% FOR IMPORTANT FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON 01-DEC-2010. NO NCRS WERE GENERATED DURING PRODUCTION. CUSTOMER QUALITY EVALUATION: CUSTOMER QUALITY (CQ) ENGINEERING INVESTIGATION: THIS COMPLAINT IS CONFIRMED. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO NONCONFOMRANCES RELATED TO THE COMPLAINT CONDITIONS WERE FOUND IN DHR REVIEWS. PART 398.96 STAGBEETLE FORCEPS 125 MM. THIS COMPLAINT IS CONFIRMED. DEVICE WAS RECEIVED AT CQ WITH ONE OF THE DISTAL TIPS BROKEN OFF. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. MOST LIKELY DUE TO CUMULATIVE WEAR OR ROUGH HANDLING FOR THE RETURNED AGED DEVICES. CORRECTED DATA: UDI, MANUFACTURE DATE. 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 DURING ROUTINE INSPECTION AND MAINTENANCE OF SET INSTRUMENTS, A POINTED REDUCTION CLAMP WAS FOUND WITH ONE OF THE TIPS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372738 STAGBEETLE FORCEPS 125MM FORCEPS HTD SYNTHES TUTTLINGEN T955386 1088698220203

    Patients

    Seq Age Sex Outcome Treatment
    1