BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LOCKING SCREW

    MDR report key: 9097718 · Received September 20, 2019

    Report

    Report Number
    8030965-2019-68495
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Report Date
    August 23, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKG
    UDI-DI
    07611819969599
    PMA / PMN Number
    K142838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. H3, H4, H6 INVESTIGATION SUMMARY THIS INVESTIGATION WAS CONDUCTED BY JABIL. VISUAL INSPECTION: PACKAGE WAS RETURNED FOR EVALUATION AND EXAMINED. THERE IS NO PRODUCT INSIDE THE PACKAGE. THE PACKAGE WAS SEALED AND NO HOLES WERE VISIBLE IN PACKAGE. PACKAGE HAS THE CORRECT LOT AND PART NUMBER. RECEIVED BAG WAS MEASURED AGAINST THE DRAWING AND (1.98¿X4.95¿) IT MEETS SPECIFICATION. DOCUMENT / SPECIFICATION REVIEW A REVIEW OF THE MANUFACTURING HISTORY FOR THIS PART DOES SHOW A COUNT DISCREPANCY AT THE PACKAGING STEP. THIS COULD INDICATE THAT ONE PACKAGE IN THE LOT COULD POTENTIALLY BE EMPTY AND THE OPERATOR WOULD BE RESPONSIBLE TO REVIEW THAT PACKAGE FOR THIS CONDITION. RISK MANAGEMENT REVIEW AND OCCURRENCE RATE HAZARD AND HAZARDOUS SITUATIONS: PACKAGE EMPTY, POTENTIALLY NOTICED INTRAOPERATIVELY WORST CASE HARM: SURGICAL DELAY ¿ SIGNIFICANT WORST CASE SEVERITY OF HARM: 3 RISK LEVEL: ACCEPTABLE. OCCURRENCE RATING = (2 COMPLAINTS, INCLUDING THIS ONE) /86,500 YEARLY UNITS) *100= 0001156%. YEARLY UNITS: PER INFORMATION FROM PP&L THE MONTHLY UNITS ARE APPROXIMATELY 7,208 WHICH IS 86,500 UNITS ANNUALLY. COMPLAINT REVIEW: A ONE YEAR COMPLAINT DATA REVIEW WAS COMPLETED FOR RELATED ISSUE CONFIRMED IN ETQ AND ONE OTHER CONFIRMED COMPLAINT WAS FOUND IN ADDITION TO THIS ONE. THE ESTIMATED YEARLY PROBABILITY OF OCCURRENCE AND HARM ARE IN ALIGNMENT WITH PRODUCT RISK ACCEPTANCE MATRIX, SECTION 9.2.3. CONCLUSION: THE PRODUCT REVIEW SUPPORTS THE COMPLAINANT¿S DESCRIPTION OF THE COMPLAINT CONDITION THEREFORE THIS IS A CONFIRMED COMPLIANT. THE CAUSE OF THE COMPLAINT CONDITION WOULD BE DETERMINED AS OPERATOR ERROR IN WHICH THE OPERATOR DID NOT THOROUGHLY REVIEW THE PACKAGES DURING THE PROCESSING OF THIS LOT. JBL-NR-0000441 HAS BEEN INITIATED FOR THIS LOT. DEVICE HISTORY PART NUMBER: 04.614.508, TI LOCKING SCREW, LOT NUMBER: 3L35509 (NON-STERILE) , LOT QUANTITY: 250, MANUFACTURING LOCATION: SUPPLIER ¿ (B)(4), PACKAGED AND RELEASED BY: MONUMENT. RELEASE TO WAREHOUSE DATE: 19-JUN-2019. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF CONFORMANCE SUPPLIED BY EPTAM DATED WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. 251 LABELS WERE PRINTED. 250 LABELS WERE USED ON PRODUCT AND 1 LABEL WAS USED ON THE PLL. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: COMPONENT PART DHRS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿NOTHING INSIDE OF THE BAG¿ DOES NOT INDICATE BREAKAGE OF THE SCREW. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 AN UNKNOWN DATE, THERE WAS NOTHING INSIDE OF THE BAG WHEN CUSTOMER RECEIVED THE PRODUCT IN THEIR WAREHOUSE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TI LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892194 TI LOCKING SCREW ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG OBERDORF SYNTHES PRODUKTIONS GMBH 3L35509 07611819969599

    Patients

    Seq Age Sex Outcome Treatment
    1