BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM

    MDR report key: 7700278 · Received July 18, 2018

    Report

    Report Number
    8030965-2018-55150
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 27, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819012561
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. PART 280.100, LOT 8961216: MANUFACTURING SITE: BALSTHAL. RELEASE TO WAREHOUSE DATE: APRIL 30, 2014. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. 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. A PRODUCT INVESTIGATION WAS COMPLETED: OUR INVESTIGATIONS HAVE SHOWN THAT THE POSITIONING GROOVE OF THE SCREW IS EXPANDED AND DAMAGED. THE COMPLAINT CONDITION CAN BE CONFIRMED, SINCE THE SCREW COULD NOT BE INSERTED INTO THE PLATE. A FUNCTIONAL TEST WITH AN AVAILABLE PLATE HAS SHOWN THAT THE SCREW COULD NOT BE INSERTED INTO THE PLATE. OUR INVESTIGATIONS HAVE SHOWN THAT THE POSITIONING GROOVE OF THE SCREW IS EXPANDED AND DAMAGED. THE COMPLAINT CONDITION CAN BE CONFIRMED, SINCE THE SCREW COULD NOT BE INSERTED INTO THE PLATE. IT IS LIKELY THAT THE CONNECTION BETWEEN THE WRENCH AND THE SCREW WAS NOT ALIGNED AS INTENDED AND THEREFORE THIS OCCURRENCE IN COMBINATION WITH A MECHANICAL OVERLOAD SITUATION COULD LED TO THE DEFORMATION OF THE SCREW. PLEASE NOTE, IN ORDER TO PREVENT SUCH OCCURRENCE AND TO ENSURE A CORRECT LOAD TRANSFER IT IS CRUCIAL TO HAVE AN APPROPRIATE CONNECTION BETWEEN THE DHS-SCREW AND THE CONNECTING SCREW (PART NUMBER 338.310), WHICH IS GUIDED THROUGH THE WRENCH (PART NUMBER 338.300). BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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 · 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. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    PATIENT YEAR OF BIRTH REPORTED TO BE (B)(6). DEVICE MALFUNCTIONED INTRAOPERATIVE. DEVICE WAS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORDS REVIEW IS 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 ON (B)(6) 2018 DURING SURGERY, ASSEMBLING OF THE DYNAMIC HIP SCREW AND PLATE WAS NOT POSSIBLE. NEITHER THAN OUT OF THE SITU. A NEW IMPLANT WAS USED TO FINALIZE THE SURGERY. THERE WAS NO PATIENT HARM. THE SURGERY WAS DELAYED FOR AN UNKNOWN LENGTH OF TIME. THIS REPORT IS FOR ONE (1) DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540958 DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 8961216 07611819012561

    Patients

    Seq Age Sex Outcome Treatment
    1