BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMACEM V+ CEMENT KIT 10 ML

    MDR report key: 7633739 · Received June 25, 2018

    Report

    Report Number
    2939274-2018-52600
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 29, 2018
    Report Date
    May 29, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LOD
    UDI-DI
    10886982262257
    PMA / PMN Number
    K170802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: PLEASE NOTE: CORRECT LOT NUMBER: 7D53200. PART: 07.702.040S; LOT: 7D53200; MANUFACTURING SITE: SELZACH; SUPPLIER: (B)(4) ; RELEASE TO WAREHOUSE DATE: 05.SEP.2017; EXPIRY DATE: 30.APR.2019. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL PHYSICAL, VISUAL AND CHEMICAL COMPOSITION CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY: INVESTIGATION FLOW: DEVICE INTERACTION / FUNCTIONAL. VISUAL INSPECTION: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) OF THE PROVIDED PHOTOS WAS NOT ABLE TO CONFIRM THE REPORTED CONDITION OF THE TRAUMACEM V+ MIXED BUT THE SURGICAL STAFF COULDN'T GET IT TO COME OUT. THE PHOTOS SHOW LABEL INFORMATION, HOWEVER NO RELEVANT PHOTOS WERE PROVIDED OF THE REPORTED COMPLAINT CONDITION OF THE TRAUMACEM V+ WAS MIXED BUT THE SURGICAL STAFF COULDN'T GET IT TO COME OUT. FUNCTIONAL TEST: A FUNCTIONAL TEST TO REPLICATE THE REPORTED CONDITION OF THE TRAUMACEM V+ MIXED BUT THE SURGICAL STAFF COULDN'T GET IT TO COME OUT COULD NOT BE PERFORMED AT CQ AS THE DEVICE WAS NOT RETURNED. THEREFORE THE REPORTED COMPLAINT CONDITION WAS NOT ABLE TO BE CONFIRMED OR REPLICATED AT CQ. DOCUMENT/SPECIFICATION REVIEW: THE COMPLAINT DEVICE WAS MANUFACTURED IN SEPTEMBER 2017. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 1150 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL PHYSICAL, VISUAL AND CHEMICAL COMPOSITION CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VERTECEM MIXER 10ML COUPLING ASSEMBLY DESIGN DRAWING WAS REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. DIMENSIONAL INSPECTION: A RELEVANT DIMENSIONAL ANALYSIS WAS NOT ABLE TO BE ATTEMPTED BECAUSE THE COMPLAINT DEVICE WAS NOT RETURNED. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE REPORTED COMPLAINT CONDITION COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT WAS NOT ABLE TO BE CONFIRMED OR REPLICATED AT CQ AND NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    PATIENT INFORMATION IS UNKNOWN. DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 THAT ON (B)(6) 2018 DURING AN UNKNOWN SURGICAL PROCEDURE, THE TRAUMACEM V+ WAS MIXED BUT THE SURGICAL STAFF COULDN'T GET IT TO COME OUT. IT HAS ALREADY CURED IN A MATTER OF FEW MINUTES. ANOTHER BATCH OF TRAUMACEM V+ WAS MIXED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: TRAUMACEM V+ SYRINGE KIT (PART: 03.702.150S, LOT: 7032535, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476366 TRAUMACEM V+ CEMENT KIT 10 ML POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT LOD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 07.702.040S 7D53200 10886982262257

    Patients

    Seq Age Sex Outcome Treatment
    1