BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    MDR report key: 7861505 · Received September 10, 2018

    Report

    Report Number
    8030965-2018-56202
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    August 21, 2018
    Report Date
    August 21, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819901643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION OF THE COMPLAINED SCREWS SHOWS THAT ALL OF THEM ARE ABSOLUTELY INTACT. NO PRODUCT FAILURE CAN BE IDENTIFIED. THE SCREWS RECEIVED ARE NOT BROKEN AS COMPLAINED. THE RECEIVED CONDITION OF THE COMPLAINED DEVICES DO NOT AGREE WITH THE COMPLAINT DESCRIPTION. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. DUE TO THE FACT AS NO PRODUCT PROBLEM COULD BE IDENTIFIED AND THE COMPLAINT CANNOT BE REPLICATED, NO FURTHER INVESTIGATIONS ARE REQUIRED. NO PRODUCT FAULT COULD BE IDENTIFIED. 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 NOT AVAILABLE FOR REPORTING. EACH PACK OF 04.503.104.04S CONTAINS 4 SCREWS. POTENTIAL LOT NUMBERS REPORTED AS L821668, L821673, L724427, L704380, L699914. DEVICE BROKE DURING INSERTION; DEVICE NOT CONSIDERED IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (510K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 AND IS CURRENTLY PENDING COMPLETION. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON USED THE SCREW AND THE BURR HOLE COVER TO CLOSE THE PATIENT¿S SKULL ON (B)(6) 2018. THE SCREW COULD NOT BE INSERTED INTO THE SKULL. EIGHT SCREWS OUT OF 16 WERE BROKEN. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. NO FURTHER INFORMATION IS PROVIDED BY THE HOSPITAL. CONCOMITANT DEVICE REPORTED: MATRIXNEURO BURR HOLE COVER F/BURRHOLES- (PART # 04.503.023S, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702489 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 07611819901643

    Patients

    Seq Age Sex Outcome Treatment
    1