BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ SYRINGE KIT

    MDR report key: 8414868 · Received March 12, 2019

    Report

    Report Number
    8030965-2019-61911
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 18, 2019
    Report Date
    February 18, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    OAR
    UDI-DI
    07611819396074
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY LOT. PART: 03.702.215S . LOT:8102588. MANUFACTURING SITE: SELZACH. SUPPLIER: SYMATESE DEVICE. RELEASE TO WAREHOUSE DATE: 16 DEC 2018. EXPIRY DATE: 01.OCT 2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED PICTURE REVIEW: NARRATIVE COULD BE CONFIRMED FROM PROVIDED PICTURES. IT IS VISIBLE THAT THE TIP/LUER LOCK OF THE SYRINGE IS MISSING/BROKEN OFF. PRODUCT WAS NOT RETURNED. HOWEVER, THE INFORMATION ABOUT THIS OCCURRENCE WAS FORWARDED TO THE SUPPLIER. SUPPLIER STATEMENT WILL BE DOCUMENTED IN COMPLAINT (B)(4). BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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 · 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. THIS DATE WAS INADVERTENTLY REPORTED AS 3/15/2019 IN THE FOLLOW UP REPORT. THE CORRECT DATE SHOULD HAVE BEEN 3/11/2019. 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 · 0

    DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING A SCREW AUGMENTATION, THE TIP OF THE BLUE VERTECEM SYRINGE (1ML) BROKE WHILE REMOVING FROM CEMENT RESERVOIR (VERCETEM V+CEMENT KIT). THE REASON FOR SCREW AUGMENTATION DUE TO BAD BONE QUALITY. OTHER SYRINGES HAD NO ISSUES AND COULD BE USED TO FINISH THE PROCEDURE. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAYED AND PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE: VERCETEM V+CEMENT KIT (PART 07.702.016S, LOT UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE HISTORY LOT: PART: 03.702.215S; LOT:8102588; MANUFACTURING SITE: (B)(4); SUPPLIER: (B)(4); RELEASE TO WAREHOUSE DATE: 16 DEC 2018; EXPIRY DATE: 01.OCT 2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY: PICTURE REVIEW: NARRATIVE COULD BE CONFIRMED FROM PROVIDED PICTURES. IT IS VISIBLE THAT THE TIP, E.G. THE LUER LOCK OF THE SYRINGE IS MISSING/BROKEN OFF. PRODUCT WAS NOT RETURNED. HOWEVER, THE INFORMATION ABOUT THIS OCCURRENCE WAS FORWARDED TO THE SUPPLIER. SUPPLIER STATEMENT WILL BE DOCUMENTED IN COMPLAINT (B)(4) (SAME EVENT DESCRIPTION, SAME PART/LOT NUMBER). BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE TIP OF THE BLUE VERTECEM SYRINGE (1ML) BROKE WHILE REMOVING FROM CEMENT RESERVOIR (VERCETEM V+CEMENT KIT). OTHER SYRINGES HAD NO ISSUES AND COULD BE USED TO FINISH THE PROCEDURE. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAYED AND PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: VERCETEM V+CEMENT KIT (PART# 07.702.016S, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207302 VERTECEM V+ SYRINGE KIT CEMENT DISPENSER OAR OBERDORF SYNTHES PRODUKTIONS GMBH 8102588 07611819396074

    Patients

    Seq Age Sex Outcome Treatment
    1