BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM

    MDR report key: 11657505 · Received April 13, 2021

    Report

    Report Number
    8030965-2021-02842
    Event Type
    Injury
    Date Received
    April 13, 2021
    Report Date
    March 19, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07611819444171
    PMA / PMN Number
    K100776
    Adverse Event
    Yes
    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. H3, H4, H6: STERILE ARTICLE: PART: 04.211.022S, LOT: 2L17039, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: NOVEMBER 07, 2018, EXPIRY DATE: OCTOBER 01, 2028. SINCE THERE IS NO ALLEGATION AGAINST PACKING OR STERILITY, A MANUFACTURING RECORD EVALUATION WAS NOT PERFORMED. NON-STERILE ARTICLE: PART: 04.211.022, LOT: H750589, MANUFACTURING SITE: SYNTHES USA HQ, INC, MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: OCTOBER 05, 2018. PART: 04.211.022, 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM, LOT: H750589 (NON-STERILE). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN PROCESS / INSPECT DIMENSIONAL / FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART: 04.211.022.999, 2.8MM TI SCREW BLANK 22MM 02.7 VARIABLE ANGLE W/SD8, LOT: H649178. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INSPECT WARM HEAD BLANK/INSPECT TURN HEAD AND POINT MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 23032, TIALNBCI2.78, LOT: H531110. CERTIFIED TEST REPORT SUPPLIED BY PERRYMAN COMPANY WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. THE PRODUCT WAS RETURNED TO US CUSTOMER QUALITY (CQ) FOR EVALUATION. THE US CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SCREW HEAD COMPONENT WAS BROKEN OFF APPROXIMATELY AT THE NECK (PROXIMAL END OF THE THREADED SHAFT). THE SCREW SHAFT COMPONENT WAS SLIGHTLY BENT AND SOME OF THE EXTERNAL THREADS WERE DEFORMED. THE BENT AND DEFORMED CONDITION ON THE SCREW SHAFT COMPONENT INDICATE THAT DEVICE WAS SUBJECTED TO SIGNIFICANT UNINTENDED/OVERT FORCE WHICH WOULD CONSISTENT WITH ATTEMPTING TO REMOVE THE BROKEN SCREW SHAFT COMPONENT. THE DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE, AND THE CAUSE FOR POST-OPERATIVE BROKEN CONDITION COULD NOT BE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FOLLOWING DRAWING REFLECTING THE CURRENT AND MANUFACTURE REVISION WAS REVIEWED: 2.7MM VARIABLE ANGLE LOCKING SCREW SELF-TAPPING, STANDARD RECESS AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS VISUAL INSPECTION OF THE RECEIVED DEVICE CONFIRMED THE BROKEN CONDITION OF LOCKING SCREW IMPLANT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    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: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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

    ADDITIONAL PROCODE: HRS. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY DUE TO BONE UNION. DURING THE PROCEDURE, THE SURGEON FOUND THAT THE HEAD PARTS OF THREE LOCKING SCREWS WERE BROKEN. BECAUSE THE HEAD PARTS WERE BROKEN, THE SCREWS COULD NOT BE REMOVED, AND THE SCREW SHAFTS REMAINED IN THE BONE. THE SURGEON SHAVED THE BONE AROUND THE SCREWS WITH A HOLLOW REAMER, AND FINALLY REMOVED THE 3 SCREW SHAFTS WITH AN EXTRACTION BOLT. AS A RESULT, THREE LARGE HOLES WERE MADE IN THE BONE. THE SURGERY WAS COMPLETED FILLING ARTIFICIAL BONE IN THE THREE HOLES. THERE WAS A THIRTY (30) MINUTE DELAY. THIS REPORT IS FOR A 2.7MM TITANIUM (TI) VARIABLE ANGLE (VA) LOCKING SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4) AND CAPTURES THE BROKEN SCREWS. THE INTRAOPERATIVE ACTION TAKEN BY THE SURGEON IS CAPTURED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557596 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM SCREW, FIXATION, BONE HWC SYNTHES GMBH 2L17039 07611819444171

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 TA| VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 TA| VA-LCP DHP 2.7/3.5 DORSO-LAT LE SHORT 3H