BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM-STERILE

    MDR report key: 6531200 · Received April 28, 2017

    Report

    Report Number
    9612488-2017-10200
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    April 3, 2017
    Report Date
    April 5, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    GWO
    PMA / PMN Number
    K123723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR (4) POSSIBLE LOT NUMBERS REPORTED: L251699, L251699, L280154, OR L280154. UDI: (01)07611819901643(10)LOT NUMBER UNKNOWN. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED FOR THE FOUR (4) POSSIBLE LOT NUMBERS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL DEVICE CODES: JEY AND GXR. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.503.104.04S, LOT# L251699. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JAN 07, 2017, EXPIRY DATE: DEC 01, 2026. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE PART # 72563, LOT# H189200, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: SEP 22, 2016. PART 21015 BP80 LOT 9954218 REVIEWED. RAW MATERIAL WAS RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF TEST RECEIVED FOR TITANIUM INGOT MEET SPECIFICATION. INSPECTION SHEET FOR INSPECT DIMENSIONAL FINAL INSPECTION MEETS ACCEPTANCE CRITERIA OF INSPECTION SHEET. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.503.104.04S, LOT# L280154. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JAN 25, 2017, EXPIRY DATE: JAN 01, 2027. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE PART# 72563, LOT# H191858 WAS MANUFACTURED IN US. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: SEP 22, 2016. PART 21015 BP80 LOT 9954218 REVIEWED. RAW MATERIAL WAS RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF TEST RECEIVED FOR TITANIUM INGOT MEET SPECIFICATION. INSPECTION SHEET FOR INSPECT DIMENSIONAL FINAL INSPECTION MEETS ACCEPTANCE CRITERIA OF INSPECTION SHEET. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. A VISUAL INSPECTION, DEVICE HISTORY RECORDS (DHR) REVIEW WAS COMPLETED AS PART OF THIS INVESTIGATION. ONE ARTICLE WITH PART# 04.503.104.04S WAS RECEIVED. SCREW HEAD WAS RECEIVED WITHOUT SHAFT/TIP SECTION. THIS COMPLAINT IS CONFIRMED. DIMENSION CHECK COULD NOT BE COMPLETED AS THE SHAFT/TIP SECTION WAS NOT RETURNED. NO DEFINITE ROOT CAUSE COULD BE DETERMINED BASED ON THE INFORMATION REPORTED. IT CAN BE PRESUMED THAT FORCE OR OTHER CIRCUMSTANCES LED TO THIS BREAKAGE. NO PRODUCT FAILURE WAS FOUND WHICH LED US TO THE CONCLUSION THAT THIS SCREW WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS TWO POSSIBLE LOT NUMBERS WERE REPORTED: L251699 OR L280154. (B)(4). 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 IS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2017, AS SURGEON WAS ATTEMPTING TO INSERT A MATRIXNEURO SCREW, THE SCREW BROKE. IT IS FURTHER REPORTED A FRAGMENT FROM THE BROKEN SCREW MAY REMAIN EMBEDDED IN PATIENT¿S BONE, BUT IT CANNOT BE VERIFIED. SURGERY WAS COMPLETED UTILIZING AN ALTERNATIVE SCREW. A DELAY OF A ¿COUPLE MINUTES¿ WAS REPORTED. THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311430 TI MATRIXNEURO SCREW SELF-DRILLING 4MM-STERILE PLATE,CRANIOPLASTY,PREFORMED, ALTERABLE GWO SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1