BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME LENGTHENER

    MDR report key: 9950035 · Received April 10, 2020

    Report

    Report Number
    8030965-2020-02808
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Date of Event
    March 18, 2020
    Report Date
    March 18, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FQP
    UDI-DI
    07611819109230
    PMA / PMN Number
    K993314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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, H6: INVESTIGATION SUMMARY THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THIS ISSUE WAS THE FIRST TIME REPORTED UNDER COMPLAINT (B)(4) , THE INVESTIGATION OF THIS COMPLAINT HAS SHOWN THAT THE LOT 4L53724 OF SYNFRAME-EXTENSION 387.338 WAS INCORRECTLY ASSEMBLED DURING THE MANUFACTURING PROCESS. DUE TO THIS MANUFACTURING ERROR FOLLOWING ACTIONS WERE INTRODUCED AND NO FURTHER INVESTIGATION FOR THIS COMPLAINT (B)(4) IS REQUIRED. JABIL NON-CONFORMANCE NC# DEPUY SYNTHES NON-CONFORMANCE , STOP SHIPMENT 2020-017, FIELD SAFETY NOTICE . H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT PART: 387.338, LOT: 4L53724, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 19. JUNE 2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE 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 THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE SYNFRAME EXTENSIONS ARE FAULTY; THE SCREWS ARE IN THE INCORRECT ORIENTATION AND THUS THE RING COULDN¿T BE ASSEMBLED. THE SURGICAL STAFF WERE ABLE TO USE BREAKABLE SYNFRAME HINGES AS EXTENDERS INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: SYNFRAME HOLDING RING (PART: 387.336, LOT: UNKNOWN, QUANTITY: 1), SYNFRAME 1/2 RING (PART: 387.337, LOT: UNKNOWN, QUANTITY: 1), SYNFRAME EXTENSION (PART: 387.338, LOT: 4L53724, QUANTITY: 1) THIS REPORT IS FOR A SYNFRAME LENGTHENER. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412960 SYNFRAME LENGTHENER LAMP, OPERATING ROOM FQP OBERDORF SYNTHES PRODUKTIONS GMBH 4L53724 07611819109230

    Patients

    Seq Age Sex Outcome Treatment
    1 SYNFRAME HOLDING RING Ø300 2PART CPL| SYNFRAME ½RING F/HOLDINGRING NO. 387.336| SYNFRAME-EXTENSION F/387.336+387.337