BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.85MM TI MATRIX SCREW SELF-TAPPING/5MM-STERILE

    MDR report key: 6483579 · Received April 11, 2017

    Report

    Report Number
    3000270450-2017-10130
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    March 22, 2017
    Report Date
    March 23, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE FRAGMENT WAS RETURNED TO THIS COMPLAINT. IT CAN BE CONFIRMED FROM OUR SIDE THAT WE HAVE RECEIVED THIS FOREIGN FRAGMENT LIKE REPORTED. AS NO ARTICLE AND NO LOT NUMBER CAN BE ASSIGNED TO THIS FRAGMENT WE WERE NOT ABLE TO CONFIRM FURTHER THE REPORTED STATEMENT FROM THE CUSTOMER. WE DO NOT KNOW WHERE THE FRAGMENT BELONGS AND UNFORTUNATELY THE COMPLAINED ARTICLE 04.511.205.01S WITH LOT L265309 WAS NOT SENT BACK FOR INVESTIGATION. THE MATERIAL FOR THIS FRAGMENT COULD NOT BEEN CHECKED AS IT IS TOO SMALL FOR EXAMINATION. NO MEASUREMENTS COULD BEEN TAKEN AS ONLY THIS FRAGMENT WAS RETURNED. FOR THE FRAGMENT NO FURTHER INVESTIGATION IS POSSIBLE. ROOT CAUSE COULD NOT BE DEFINED. 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 NARRATIVE: PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE WAS NOT EXPLANTED COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. ARTICLE 04.511.205.01S / L265309. PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 13.JAN.2017 EXPIRY DATE: 01.JAN.2027. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE 04.511.205.01C / H262292 WAS MANUFACTURED IN US. MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 27-DEC-2016; PART NO: 04.511.205.01C, LOT NO: H262292 (NON-STERILE) - 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. QUANTITY (B)(4). COMPONENTS REVIEWED: RAW MATERIAL PART (B)(4), LOT H072911 REVIEWED. RAW MATERIAL RECEIVED FROM SUPPLIER. PRODUCT CERTIFICATE RECEIVED AND IT MEET SPECIFICATION. RAW MATERIAL REWORK FOR CUT BARS IN HALF WAS ISSUED. INSPECTION SHEET FOR INSPECT DIMENSIONAL FINAL INSPECTION MEET INSPECTION ACCEPTANCE CRITERIA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 A LE FORT I OSTEOTOMY PROCEDURE ON (B)(6) 2017, SURGEON NOTED A FIBROUS FOREIGN MATTER ROSE SPIRALLY WHEN TURNING THE SCREWDRIVER TO INSERT THE SCREW. SURGEON STOPPED INSERTING THE SCREW AND CHECKED THE FOREIGN MATTER AND FOUND IT TO BE A FIBROUS METAL PIECE, ASSUMED TO BE FROM THE SCREW. THE FIBROUS METAL PIECE WAS REMOVED FROM PATIENT¿S BODY. SURGEON NOTED THE SCREW APPEARED TO BE SATISFACTORY TO USE AND CONTINUED IMPLANTING THE SAME SCREW. SURGEON COMMENTED THAT THE INSERTION ANGLE OF THE SCREW WAS NOT PERPENDICULAR TO THE PLATE AND IT IS ASSUMED THE THREADED PORTION OF THE SCREW RUBBED AGAINST THE PLATE AND GENERATED THE FIBROUS METAL PIECE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. CONCOMITANT DEVICES REPORTED: PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) MATRIX SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264731 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM-STERILE BONE PLATE JEY SYNTHES SELZACH L265309

    Patients

    Seq Age Sex Outcome Treatment
    1