BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLOFIT ALLOCLASSIC, PLUGS FOR SCREW HOLES

    MDR report key: 8149893 · Received December 11, 2018

    Report

    Report Number
    0009613350-2018-01205
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 13, 2018
    Report Date
    January 30, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: A TREND CONSIDERING THE FOLLOWING EVENT WAS IDENTIFIED: MISSING COMPONENTS IN PACKAGING HOWEVER, NO POTENTIAL RELATION OF THE INVESTIGATED EVENT COULD BE IDENTIFIED TO ANY DEVIATIONS OR NCR'S NOR COULD ANY POTENTIAL RELATION OF THE INVESTIGATED EVENT BE IDENTIFIED TO A PRODUCT CHARACTERISTIC WHICH WAS INSPECTED BY A LESS THAN 100% SCOPE. FURTHER INVESTIGATION HAS BEEN INITIATED. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THERE WAS ONLY 1 PLUG CONTAINED IN THE PACKAGING FOR PLUGS FOR SCREW HOLES INSTEAD OF THE REQUIRED 7 PLUGS. THIS EVENT OCCURRED DURING AN INITIAL SURGERY FOR THE PATIENT. THE PROCEDURE HAS BEEN COMPLETED WITHOUT SCREW HOLES. REVIEW OF RECEIVED DATA: NO OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: NO DEVICE OR PACKAGING HAS BEEN RETURNED. REVIEW OF PRODUCT DOCUMENTATION: REVIEWING THE DHR 2955750 SHOWS THAT THE PACKAGING OF ONE SKU WITH ITEM# 01.00004.001 HAS A QUANTITY OF (B)(4) PIECES. A MANUFACTURING/PLANNING ISSUE IS ASSUMED (WRONG BILL OF MATERIAL). IT WAS REPORTED THAT THERE WAS ONLY 1 PLUG CONTAINED IN THE PACKAGING PLUGS FOR SCREW HOLES, INSTEAD OF THE 7 REQUIRED PLUGS. THIS EVENT OCCURRED DURING AN INITIAL SURGERY FOR THE PATIENT. THE PROCEDURE HAS BEEN COMPLETED WITHOUT SCREW HOLES. BASED ON THE RETURNED PRODUCT AND THE GIVEN INFORMATION THE COMPLAINT COULD BE CONFIRMED. NO DEVICE OR PACKAGING HAS BEEN RETURNED FOR INVESTIGATION. HOWEVER, REVIEWING THE DHR 2955750 CONFIRMS THAT THE PACKAGING OF A SKU WITH ITEM# 01.00004.001 HAS A QUANTITY OF (B)(4) PIECES. THE MOST LIKELY ROOT CAUSE FOR THIS DISCREPANCY IS A MANUFACTURING/PLANNING ISSUE (WRONG BILL OF MATERIAL). BASED ON THE AVAILABLE INFORMATION FURTHER INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE NECESSITY OF POTENTIAL CORRECTIVE AND/OR PREVENTIVE ACTIONS. THE FIELD ACTION FA 2018-07 (ZFA 2018-00632) HAS BEEN INITIATED. A PRODUCT REMOVAL HAS BEEN CONDUCTED (USA NOT AFFECTED). ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO EVENT UPDATE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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

    THERE WAS ONLY 1 PLUG CONTAINED IN THE PACKAGING FOR PLUGS FOR SCREW HOLES INSTEAD OF THE REQUIRED 7 PLUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989374 ALLOFIT ALLOCLASSIC, PLUGS FOR SCREW HOLES ALLOFIT ALLOCLASSIC, PLUGS FOR SCREW HOLES KWA ZIMMER GMBH N/A 2955750

    Patients

    Seq Age Sex Outcome Treatment
    1