BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/115MM-STERILE

    MDR report key: 8267955 · Received January 22, 2019

    Report

    Report Number
    8030965-2019-60166
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    December 25, 2018
    Report Date
    January 1, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819055308
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 280.150S, LOT: 9940481. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: MAY 11, 2016, EXPIRY DATE: APR 01, 2026. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT ON THE DISTAL END OF THE DEVICE IS DEFORMED FROM USE, THUS CONFIRMING THE COMPLAINT DESCRIPTION. FURTHERMORE, THE PART HAS ALSO SOME DENTS VISIBLE AT THE THREAD, OTHERWISE IT IS IN A GOOD CONDITION. DURING INVESTIGATION THE DIAMETER 7.90 0/-0.05MM GOT MEASURED WITH THE MICROMETER. THE MEASURE RESULT FAILED (SPECIFICATION 8.16MM), BASED ON THE ALREADY MENTIONED DEFORMATION. THE EXACT REASON FOR THIS OCCURRENCE COULD NOT BE DETERMINED. IT CAN BE ASSUMED THAT THE EXCESSIVE FORCE LED TO THIS DAMAGE OR/AND THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A DYNAMIC HIP SCREW SURGERY. DURING THE SURGERY, IT WAS NOTED THAT A PLATE WOULD NOT SLIDE OVER THE DHS/DCS LAG SCREW ON INSERTION AS IT SHOULD AND USUALLY DOES. THERE WAS NO ISSUE WITH LOADING THE DHS/DCS LAG SCREW ONTO THE INSERTION DEVICE BEFORE THE ATTEMPT TO INSERT IT. THE DHS/DCS LAG SCREW WAS INSERTED AND THE ISSUE WAS DETECTED ONLY WHEN IT WAS TIME TO SLIDE THE PLATE OVER. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY FIVE (5) MINUTES. THIS IS THE TIME IT TOOK TO REALIZE THAT THE DHS/DCS LAG SCREW WAS THE REASON THAT THE UNKNOWN PLATE COULD NOT GET IN AND THE DECISION WAS MADE BY THE SURGEON TO OPEN ANOTHER SCREW THAT HAD SAME REFERENCE NUMBERS, WITH DIFFERENT LOT NUMBERS. THE PLATE WOULD NOT FIT OVER THE FIRST DHS/DCS LAG SCREW, BUT FIT EASILY OVER THE SECOND LAG SCREW OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE PLATE WAS INSERTED WITH THE USE OF A SECOND SCREW OF THE SAME PRODUCT. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS FOR ONE (1) DHS/DCS LAG SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62374 DHS®/DCS® LAG SCREW 12.7MM THREAD/115MM-STERILE APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 9940481 07611819055308

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR