BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ANATOMICAL SHOULDER INSTRUMENT

    MDR report key: 7068532 · Received November 29, 2017

    Report

    Report Number
    0009613350-2017-01638
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Report Date
    March 29, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWS
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2017-01672. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. THE MISSING INFORMATION WAS REQUESTED AT COMPLAINANT THE LATEST ONE ON JANUARY 5, 2018 BUT WAS NOT AVAILABLE. TREND ANALYSIS: NO TREND ANALYSIS COULD BE PERFORMED AS NO ITEM NUMBER(S) IS/ARE AVAILABLE. DEVICE HISTORY RECORDS (DHR): AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THERE WERE HURDLES WITH THE TRIAL HEADS CATCHING ON THE GLENOID CAUSING DISRUPTION TO THE CONSTRUCT WHILE PERFORMING THE TRIAL REDUCTION. IT IS STATED THAT THE ISSUE DOES NOT LEAD TO ANY DELAYS IN SURGERY OR ANY HARMS, BUT IT IS MORE OF AN INCONVENIENCE FOR THE SURGEON WHILE TRYING TO ACCESS WHETHER THERE IS POSTERIOR INSTABILITY. THIS IS MENTIONED TO BE A PROBLEM FOR THE OLD ANATOMIC SYSTEM AS WELL. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: SURGICAL TECHNIQUE DEMONSTRATES CORRECT USE OF INSTRUMENTS FOR TRIALLING (06.02651.012) ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: DAMAGE TO GLENOID DURING TRIAL REDUCTION, OR INCORRECT HEIGHT DETERMINATION FROM TRIALLING DUE TO HOLE IN THE TRIAL HEAD COMPROMISES CORRECT IDENTIFICATION OF HEIGHT TO USE IN THE DEFINITIVE PROSTHESIS AND DOES NOT SUPPORT EFFECTIVE TRIALLING: POSSIBLE: SURGEON MIGHT NOT BE IDENTIFYING THE CORRECT HEIGHT TO USE, WHICH LEADS TO INEFFECTIVE TRIALLING. CONCLUSION SUMMARY: NO REF/LOT NUMBER WAS AVAILABLE FOR THE COMPLAINED PRODUCT. THEREFORE, THE DHR CHECK COULD NOT BE PERFORMED. HOWEVER, ACCORDING COMPLAINT DESCRIPTION IT IS ASSUMED THAT THE PRODUCT BELONGS TO ANATOMICAL SHOULDER DOMELOCK TRIAL HEADS GROUP. POSSIBLE REASON FOR THE REPORTED EVENT CAN BE THAT THE HOLE IN THE TRIAL HEAD COMPROMISES CORRECT IDENTIFICATION OF HEIGHT TO USE IN THE DEFINITIVE PROSTHESIS, LEADING TO UNSUCCESSFUL TRIALLING AND DAMAGE TO GLENOID DURING TRIAL REDUCTION. THE FEATURE IN QUESTION IS EQUIVALENT TO THE PREDICATE AS HEADS, FOR WHICH A COMPLAINTS SUMMARY AND FAMILY SUMMARY DO NOT IDENTIFY ANY NEGATIVE TRENDS FOR THE PREDICATES FOR THESE INSTRUMENTS. MOREOVER, SURGICAL TECHNIQUE DEMONSTRATES CORRECT USE OF INSTRUMENTS FOR TRIALLING. 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. BASED ON THE INVESTIGATION RESULTS, THIS EVENT IS NOW RE-ASSESSED AS NOT REPORTABLE. ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE THE HURDLES WITH THE PROVISIONAL HEAD CATCHING ON THE GLENOID CAUSING DISRUPTION TO THE CONSTRUCT WHEN PERFORMING TRIAL REDUCTION. FURTHERMORE IT WAS REPORTED THAT THIS ISSUE DOES NOT DELAY SURGERY OR CAUSE ANY HARM BUT IS AN INCONVENIENCE FOR THE SURGEON. NOTES: THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS AN INSTRUMENT. HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848973 UNKNOWN ANATOMICAL SHOULDER INSTRUMENT KWS ZIMMER GMBH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 ANAT. SHOULDER GLENOID IMPLANT, REF:UNK, LOT:UNK