BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZNN, CMN LAG SCREW PIN SLEEVE, 3.2 MM, ASIA

    MDR report key: 6188520 · Received December 20, 2016

    Report

    Report Number
    0009613350-2016-01462
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 10, 2016
    Report Date
    March 27, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO BE PERFORMED, AS THE DEVICE(S) WERE NOT AT HAND FOR INVESTIGATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION IS CONDUCTED WITH OUTCOME AS FOLLOWS. TREND ANALYSIS: NO TREND IDENTIFIED. DEVICE HISTORY RECORDS (DHR): THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. EVENT SUMMARY: IT WAS REPORTED THAT THE LAG SCREW PIN SLEEVE WAS BROKEN DURING THE SURGERY. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: - THE CORRECT LAG SCREW PLACEMENT AND THE USE OF THE INSTRUMENT REF 00-2490-043-20 IS DESCRIBED IN THE SURGICAL TECHNIQUE. ROOT CAUSE DETERMINATION USING DFMEA: - SLEEVE FRACTURES OR BENDS DUE TO EXCESSIVE FORCE APPLIED TO PART, IMPROPER MATERIAL SELECTION AND/OR DESIGN. - POSSIBLE: IT IS POSSIBLE THAT EXCESSIVE FORCE APPLIED TO PART. - FRACTURE OF INSTRUMENT/CASE DUE TO GENERAL CORROSION (CREVICE, PITTING, GALVANIC). - POSSIBLE: AS THE DEVICE WAS NOT RETURNED, THIS POINT CANNOT BE EXCLUDED. - FRACTURE OF INSTRUMENT/CASES DUE TO CORROSION DUE TO RAW MATERIAL COMBINATIONS. - NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW DEFINED IN COMPLAINT REGISTRATION, SYSTEMATIC ASSESSMENT DEFINED IN COMPLAINT INVESTIGATION OR IN THE CURRENT PMS PROCESS POST MARKET SURVEILLANCE. CONCLUSION SUMMARY: NEITHER OPERATIVE NOTES, OFFICE VISIT NOTES OR PHOTOS OF THE INSTRUMENT WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE CORRECT LAG SCREW PLACEMENT AND THE USE OF THE INSTRUMENT REF 00-2490-043-20 IS DESCRIBED IN THE SURGICAL TECHNIQUE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZNN, CMN LAG SCREW PIN SLEEVE, 3.2 MM, ASIA WAS FRACTURED.NO FURTHER INFORMATION IS AVAILABLE AT THAT TIME.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE ZNN, CMN LAG SCREW PIN SLEEVE, 3.2 MM, ASIA WAS FRACTURED. WHEN THE SURGEON INSERTED THE SLEEVE INTO THE OUTER PIPE, THE SPRING OF THE SLEEVE WAS FRACTURED. THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT AND NO PIECES REMAINED IN THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839487 ZNN, CMN LAG SCREW PIN SLEEVE, 3.2 MM, ASIA ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT HSB ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other