BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIF SIZER HANDLE

    MDR report key: 4861823 · Received June 23, 2015

    Report

    Report Number
    1719045-2015-10402
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Report Date
    June 10, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    GDZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DRH REVIEW ¿ ENVISION MANUFACTURING INC. MANUFACTURED THE ALIF SIZER HANDLE, P/N 389.150, LOT # 4667995, 4743077, 4761280, SUPPLIER LOT # 7858-1. THERE WERE THREE DHR LOTS TO REVIEW. LOT # 4667995: DATED OCTOBER 15, 2003, WAS FOR 12 PARTS. THE CERTIFICATE OF COMPLIANCE (DATED OCTOBER 13, 2003) INDICATES THE PART WAS MANUFACTURED TO P/N 389.150 AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. 12 PARTS WERE RELEASED TO THE WAREHOUSE ON OCTOBER 16, 2003. LOT # 4743077 DATED MARCH 09, 2004, LINE 2, FOR 4 PARTS. THE CERTIFICATE OF COMPLIANCE (DATED FEBRUARY 05, 2004) INDICATES THE PARTS WERE MANUFACTURED TO P/N 389.150, AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION. MRR WAS WRITTEN FOR THE M4 X 0.7 - 6G, THREAD GO / NO-GO GAGE ¿ THE NO-GO MEMBER OF THE GAGE WAS NONCONFORMING ON 1 PART OUT OF 4 IN THE LOT. ONE PART WAS RETURNED TO THE SUPPLIER (RTS) AND THE MRR WAS CLOSED ON MARCH 11, 2004. 3 PARTS WERE RELEASED TO THE WAREHOUSE ON MARCH 26, 2004. LOT # 4761280: DATED APRIL 08, 2004, WAS FOR 1 PART. THE CERTIFICATE OF COMPLIANCE (DATED APRIL 07, 2004) INDICATES THE PART WAS MANUFACTURED TO P/N 389.150, AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. ONE PART WAS RELEASED TO THE WAREHOUSE ON APRIL 20, 2004. THE ALIF SIZER HANDLE WAS RELEASED ON AUGUST 21, 2001. 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

    PRODUCT INVESTIGATION SUMMARY: TWO ALIF SIZER HANDLES (PART 389.150 / LOT 7858-1 AND U126012) WERE RETURNED WITH THE FOLLOWING COMPLAINT DESCRIPTIONS: ¿THE THREADED TIP OF THE INNER SHAFT BROKE OFF¿ [AND]¿ THE THREADS ON THE END ARE WORN DOWN AND SMOOTH¿. THE RETURNED INSTRUMENTS WERE EXAMINED AND THE COMPLAINT CONDITIONS WERE ABLE TO BE CONFIRMED. THE ROOT CAUSE FOR LOT 7858-1 WAS DEEMED MISUSE/ABUSE AS THE COMPLAINT DESCRIPTION NOTES THAT THE INSTRUMENT WAS DROPPED, CAUSING THE TIP FAILURE. THE RETURNED INSTRUMENTS WERE EXAMINED AND IN EACH INSTANCE THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED. THE THREADED TIP FOR LOT 7858-1 IS BROKEN AS THE DISTAL 5MM HAS BROKEN OFF AND WAS NOT RETURNED. THE MATERIAL AT THE FRACTURE SITE APPEARS HOMOGENOUS. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. THE DEVICE HISTORY RECORD RELATING TO THE LOT NUMBER FOR BOTH RETURNED PARTS WAS EXAMINED AND NO COMPLAINT-RELATED ISSUES WERE FOUND. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PART # 389.150, LOT# 7858-1 ¿ THE THREADED TIP OF THE INNER SHAFT BROKE OFF. A DISTRACTOR BULLET WAS LEFT ON THE TIP DURING THE CLEANING PROCESS. THE PAN HOLDING THE ITEMS FELL ON THE FLOOR AND THE TIP WITH THE BULLET BROKE OFF AND WAS LOST. IT WAS ALSO REPORTED THAT PART # 389.150 LOT L# U126012 ¿ THE THREADS ON THE END ARE WORN DOWN AND SMOOTH, NO REPORTED CASE OR PATIENT IMPACT. THESE EVENTS OCCURRED IN STERILE PROCESSING, NOT DURING SURGERY. NO REPORTED PATIENT INVOLVEMENT OR PROCEDURE HARM NOTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406732 ALIF SIZER HANDLE HANDLE, SCALPEL GDZ SYNTHES MONUMENT 7858-1

    Patients

    Seq Age Sex Outcome Treatment
    1