BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI HDLSS COMPRESSION SCR 24MM/SHORT THREAD-STERILE

    MDR report key: 7652715 · Received June 29, 2018

    Report

    Report Number
    8030965-2018-54742
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 7, 2018
    Report Date
    June 7, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819972889
    PMA / PMN Number
    K021556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. DEVICE EVALUATED BY MFR, DEVICE MANUFACTURE DATE: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: PART NO: 04.226.224S, LOT NO: 9043735: MANUFACTURING LOCATION: SELZACH, SUPPLIER: FRUEH AG, RELEASE TO WAREHOUSE DATE: 03.JUL.2014, EXPIRY DATE: 01.JUN.2024. NON-STERILE 04.226.224 / 9033064 WAS MANUFACTURED IN GRENCHEN: RELEASE TO WAREHOUSE DATE: 18.JUN.2014: THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 24 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND MATERIAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO ISO-5832-11 SPECIFICATION FOR IMPLANTS FOR SURGERY. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE EVALUATED BY MFR: A PRODUCT INVESTIGATION WAS CONDUCTED. THE BROKEN DEVICE WAS SENT TO MANUFACTURING SITE FOR DETAILED INVESTIGATION. ALL THE RELEVANT FEATURES WERE MEASURED ACCORDING TO THE RELEVANT DRAWING AND HAVE PASSED ALL THEIR SPECIFICATIONS EXCEPT FOR THE THREAD LENGTH WHICH IS DAMAGED AND NOT MEASURABLE (SEE PICTURES ABOVE), ALSO THE FLUTES ARE NOT MEASURABLE BECAUSE OF DAMAGES. BESIDES, DURING THE MANUFACTURING PROCESS, THESE RELEVANT FEATURES WERE INSPECTED AND DOCUMENTED ACCORDING TO THE INSPECTION SHEET. THE RESULTS SHOWED THAT THE SCREW IS ACCORDING TO ITS SPECIFICATIONS. THEREFORE, THIS SCREW WAS MANUFACTURED ACCORDING TO ITS QUALITY STANDARDS AND A MANUFACTURING ISSUE CAN BE EXCLUDED. THE COMPLAINT RECEIVED CONDITION AGREES WITH THE COMPLAINT DESCRIPTION SINCE THE SCREW IS BROKEN AT THE TIP AS CLAIMED BY THE CUSTOMER. HOWEVER, FROM THE MANUFACTURING POINT OF VIEW THIS COMPLAINT IS RATED AS NOT VALID SINCE NO MANUFACTURING ISSUE WAS DETECTED. THEREFORE, NO FURTHER ACTIONS HAVE BEEN TAKEN. CORRECTED DATA: CONCOMITANT MEDICAL PRODUCTS: DATE DEVICE RECEIVED BY MANUFACTURE. 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

    THIS PATIENT¿S INFORMATION IS UNKNOWN. DEVICE BROKE DURING INSERTION; DEVICE NOT CONSIDERED IMPLANTED/EXPLANTED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH 2.4 HEADLESS COMPRESSION SCREWS (HCS) WAS PERFORMED ON (B)(6) 2018 TO TREAT THE FRACTURES IN THE JOINT OF THE RADIUS HEAD. TWO GUIDE WIRES WERE INSERTED PARALLEL TO JOINT¿S SIDE UNTIL THE GUIDE WIRES REACHED THE CONTRALATERAL SIDE. ONLY THE CORTEX ON THE SURGEON¿S SIDE WAS DRILLED, AND TWO HCS SCREWS WERE INSERTED. THE SURGEON HAD TO INSERT THE FIRST HCS SCREW A LITTLE FORCEFULLY AND WHEN THE SECOND HCS SCREW REACHED THE CONTRALATERAL CORTEX, ITS TIP BROKE. THEN, THIS SCREW BREAKAGE FURTHER CAUSED ONE GUIDE WIRES IN QUESTION TO BE BROKEN, TOO. AFTER THE SURGEON REMOVED THE FRAGMENTS OF THE 2ND SCREW AND THE GUIDE WIRE, HE FOUND ANOTHER BREAKAGE ON THE 1ST SCREW. AFTER REMOVING THE FRAGMENTED TIP OF THE 1ST SCREW, THE SURGEON REPLACED WITH REPLACING SCREWS AND COMPLETED THE REST OF THE SURGERY WITHIN A 30-MINUTE DELAY. THEREFORE, THREE DEVICES IN QUESTION WERE BROKEN, BUT NO FRAGMENT REMAINED IN THE PATIENT¿S BODY WHO HAD ROBUST BONE QUALITY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH PATIENT¿S OUTCOME REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 2.4MM TI HEADLESS COMPRESSION SCREW 24MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492993 2.4MM TI HDLSS COMPRESSION SCR 24MM/SHORT THREAD-STERILE SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 9043735 07611819972889

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR