BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILE

    MDR report key: 7689819 · Received July 16, 2018

    Report

    Report Number
    2939274-2018-52888
    Event Type
    Injury
    Date Received
    July 16, 2018
    Date of Event
    June 20, 2018
    Report Date
    June 20, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LOD
    UDI-DI
    10886982262257
    PMA / PMN Number
    K170802
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. : A5: PATIENT ETHNICITY IS UNKNOWN. H3, H4, H6: PART: 07.702.040S; LOT: 7D53200; MANUFACTURING SITE: SELZACH; SUPPLIER: AAP BIOMATERIALS GMBH; RELEASE TO WAREHOUSE DATE: SEPTEMBER 05, 2017; EXPIRY DATE: APRIL 30, 2019 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 ID/INITIALS, GENDER AND WEIGHT ARE UNKNOWN DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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 DURING A PROCEDURE FOR A HIP FRACTURE, THE TRAUMACEM V+ INJECTABLE BONE CEMENT DID NOT PROPERLY LOAD INTO THE SYRINGE KIT AND BECAME STUCK. AS A RESULT, THE SYRINGE KIT COULD NO LONGER BE USED. THE FENESTRATED HELICAL BLADE WAS USED WITHOUT THE BONE CEMENT. THE ATTEMPT TO LOAD THE BONE CEMENT INTO THE SYRINGE KIT OCCURRED ON THE BACK TABLE WITH THE SCRUB TECHNICIAN. THE SURGEON CONTINUED TO IMPLANT THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) CONSTRUCT CONSISTING OF A NAIL, HELICAL BLADE AND LOCKING SCREW AFTER IT WAS DETERMINED THAT THE BONE CEMENT COULD NOT BE ADDED TO THE FENESTRATED HELICAL BLADE. THERE WAS NO SURGICAL DELAY. INTRAOPERATIVE X-RAYS STANDARD FOR THE PROCEDURE WERE TAKEN. THE USE OF BONE CEMENT WAS A DECISION THAT WAS MADE INTRAOPERATIVELY, FOR AN ADDITIVE STRENGTH TO THE HELICAL BLADE. IT WAS NOT A PART OF THE PATIENT¿S ORIGINAL TREATMENT PLAN. ALTHOUGH THE BONE CEMENT WAS NOT USED, IT DID NOT AFFECT THE TREATMENT PLAN FOR THE PATIENT OR CHANGE THE PATIENT¿S OUTCOME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS INTENDED AND THE PATIENT WAS REPORTED TO BE STABLE. CONCOMITANT DEVICES REPORTED: TRAUMACEM V+ SYRINGE KIT (PART 03.702.150S, LOT 7032535, QUANTITY 1) AND FENESTRATED HELICAL BLADE (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531254 TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILE POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT LOD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 07.702.040S 7D53200 10886982262257

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention