BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 34MM

    MDR report key: 7773369 · Received August 10, 2018

    Report

    Report Number
    8030965-2018-55617
    Event Type
    Injury
    Date Received
    August 10, 2018
    Report Date
    July 9, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819231023
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. : B5 D10 H3, H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 214.834S, LOT# L477734. MANUFACTURING LOCATION: GRENCHEN, RELEASE TO WAREHOUSE DATE: JUL 05, 2017, EXPIRY DATE: JUN 01, 2027. 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 MATERIAL, DIMENSIONAL, AND VISUAL 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. THE REVIEW HAS SHOWN THAT THE BLANK 214.034.999 WITH LOT H288082 WAS USED FOR THIS SCREW, THEREFORE A DHR REVIEW FOR THE BLANK FROM MONUMENT NEEDS TO BE PERFORMED: BLANK MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: MOVED TO BLANK STORAGE ON 03-FEB-2017 PART NUMBER: 214.034.999, 4.6MM SCREW BLANK 34MM 04.5 CORTEX SCREW W/3.5 HEX, LOT NUMBER: H288082 (NON-STERILE) WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. COMPONENT PART(S) REVIEWED: PART NUMBER: 13008, 316LC*RI4.58, LOT NUMBER: H130052 CERTIFICATE OF TESTS RECEIVED FROM CARPENTER DATED 25-MAY-2016 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 21-JUN-2016 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE VISUAL INSPECTION OF PART 214.834 WITH LOT L477734 HAS SHOWN THAT THE THREAD FLANKS OF THE RECEIVED SCREW ARE TOTALLY FLATTENED, THERE IS SLIGHT BURR AT THE FLATTENED THREAD FLANKS VISIBLE. THE DEVICE WAS RETURNED WITHOUT AN ALLEGATION AGAINST IT, THERE IS NO INDICATION THAT THERE WAS ANY ISSUE WITH THE FIXATION OF PLATE. THE SCREWS WERE CAPTURED AS IMPACTED PART DUE TO THE DAMAGES, WHICH WERE DETECTED DURING THE DEFINITION OF THE INVESTIGATION REQUIREMENTS. THE COMPLAINT IS IN RELATION TO THE CORTEX SCREW NOT CONFIRMED REGARDING THE CUT OUT OF THE DHS SCREW, IT IS CONFIRMED DUE TO THE DETECTED DAMAGE AT THE RECEIVED SCREWS. AS STATED ABOVE, THE THREAD FLANKS ARE FLATTENED. THE VISUAL INSPECTION OF THE ALSO RECEIVED PLATE 02.224.224 HAS SHOWN THAT ALL FOUR HOLES HAVE A DAMAGE ON TOP OF THE HOLE AND DIAGONALLY SHIFTED ON THE BOTTOM OF THE HOLE. THIS IS A CLEAR INDICATION FOR A STRONG CONTACT BETWEEN THE SCREW AND THE PLATE BY AN EXCESSIVE INSERTION ANGLE OF THE SCREW. FINALLY, THIS CONTACT CAUSED THE DAMAGE OF THE THREAD FLANKS. 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. H11 CORRECTED DATA: B4: THE CORRECT DATE IS 7/9/2018. 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 · 0

    IT WAS FURTHER CLARIFIED THAT CUT-OUT MEANS THE DHS SCREW MIGRATED THROUGH THE FEMORAL HEAD INTO THE ACETABULUM.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. IT IS UNKNOWN WHEN SCREW BECAME DAMAGED. ADDITIONAL PROCODE: KTT. DATE OF IMPLANTATION IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER PHONE NUMBER AND EMAIL ADDRESS ARE UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. (B)(4). 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 THE (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE RIGHT DYNAMIC HIP SCREW/DYNAMIC CONDYLAR SCREW (DHS/DCS) PLATE AND DHS/DCS ONE-STEP LAG SCREW ON UNKNOWN DATE FOR UNKNOWN PURPOSE. ON (B)(6) 2018, PATIENT WAS RETURNED TO SURGERY FOR REMOVAL OF THE DHS/DCS LAG SCREW AND REVISED TO A RIGHT TOTAL HIP REPLACEMENT (THR). THE PLATE AND FOUR CORTEX SCREWS WERE ALSO REMOVED. IT WAS REPORTED THAT THE LAG SCREW HAD CUT OUT. THE SURGEON BELIEVES THAT THE CUT OUT WAS CAUSED FROM A BONE FAILURE POINT OF VIEW; THE IMPLANT WAS IN A GOOD POSITION INITIALLY AND THERE WAS NO VISIBLE SIGN OF DAMAGE TO IT AT CONVERSION TO THR. SURGICAL OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 4.5 MM CORTEX SCREW SELF-TAPPING 34 MM. THIS IS REPORT 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613066 4.5MM CORTEX SCREW SELF-TAPPING 34MM SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH L477734 07611819231023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention