BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE

    MDR report key: 11706433 · Received April 22, 2021

    Report

    Report Number
    8030965-2021-03163
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    March 25, 2021
    Report Date
    March 25, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07612334089687
    PMA / PMN Number
    K172872
    Removal / Correction Number
    N/A
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6- VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT PL 1-HO F/FEM NECK SYST TAN WAS HAVING NICKS /SCRATCHES INSIDE THE DEVICE. WHICH ARE CLEARLY VISIBLE NO OTHER DEFECTS WERE OBSERVED THE DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE REVEALED THAT THE DEVICE WAS CONFORMING TO THE SPECIFICATIONS. THE FUNCTIONAL TEST CANNOT BE PERFORMED AS ALL MATING DEVICES WERE NOT RETURNED. THE OBSERVED SCRATCHES CONDITION OF THE COMPONENTS IN THE PL 1-HO F/FEM NECK SYST TAN DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED/OVERT FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED PL 1-HO F/FEM NECK SYST TAN WAS HAVING SCRATCHES /NICKS ISSUE. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS PROBABLE THAT THE 1-HO F/FEM NECK SYST TAN WAS HAVING SCRATCHES DUE TO THE UNINTENDED/OVERT FORCES.THE ALLEGED DEVICE INTERACTION ISSUE CANNOT BE CONFIRMED SINCE THE MATING DEVICE WAS NOT RECEIVED FOR THE ANALYSIS,. 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 HISTORY LOT ==> PART: 04.168.000S LOT: 75P7748 MANUFACTURING SITE: GRENCHEN RELEASE TO WAREHOUSE DATE: 06. NOVEMBER 2020 EXPIRY DATE: 01 OCTOBER 2030 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER#75P7748, AND NO NON CONFORMANCES WERE IDENTIFIED THE LOT NUMBER#60P7462 CORRESPONDS TO THE NON STERILE PART #60123890. PART: 60123890 LOT: 60P7462 MANUFACTURING SITE: GRENCHEN RELEASE TO WAREHOUSE DATE: 08. JULY 2020 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NON STERILE LOT, AND NO NON CONFORMANCES WERE IDENTIFIED.,PART: 04.168.000S LOT: 75P7748 MANUFACTURING SITE: GRENCHEN RELEASE TO WAREHOUSE DATE: 06. NOVEMBER 2020 EXPIRY DATE: 01 OCTOBER 2030 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER#75P7748, AND NO NON CONFORMANCES WERE IDENTIFIED THE LOT NUMBER#60P7462 CORRESPONDS TO THE NON STERILE PART #60123890. PART: 60123890 LOT: 60P7462 MANUFACTURING SITE: GRENCHEN RELEASE TO WAREHOUSE DATE: 08. JULY 2020 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NON STERILE LOT, AND NO NON CONFORMANCES WERE IDENTIFIED. DEVICE HISTORY BATCH ==> NULL,NULL DEVICE HISTORY REVIEW ==> NULL,NULL 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. PART: 04.168.000S LOT: 75P7748 MANUFACTURING SITE: (B)(4) RELEASE TO WAREHOUSE DATE: NOVEMBER 06, 2020 EXPIRY DATE: OCTOBER 01, 2030 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON CONFORMANCES WERE IDENTIFIED. ON THE RECEIVED PICTURES, WE ONLY CAN CONFIRM THAT THE PLATE (PL 1-HO F/FEM NECK SYST TAN) WAS SHAVED AS REPORTED. THE FUNCTIONAL ISSUE WITH THE OTHER DEVICES, PL 2HO F/FEM NECK SYST TAN, INSERT HANDLE AND INS F/INSERTION HANDLE, COULD NOT BE CONFIRMED WITH THE AVAILABLE PICTURES. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 · 0

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT THE SURGERY FOR LEFT FEMORAL NECK FRACTURE. THE SURGEON ATTACHED THE 2-HOLE PLATE TO THE INSERT HANDLE AND TRIED TO TIGHTEN THE BLACK SCREW OF THE INSERT MANUALLY, BUT THE CONNECTION WAS STIFF, AND HE COULD NOT TIGHTEN THE BLACK SCREW TO THE INSERT HANDLE; IT WAS ASSUMED THAT THERE WAS A PROBLEM WITH THE PLATE. THE SURGEON EXCHANGED THE PLATE TO 1-HOLE PLATE, BUT THE SAME EVENT OCCURRED. WHEN THE PLATE WAS REMOVED FROM THE INSERT HANDLE AND THE BOLT INSERTION PORT SIDE OF THE PLATE WAS CHECKED, IT WAS FOUND THAT THE PLATE WAS SHAVED BY THE TIP OF THE INSERT. THE INSERT WAS REMOVED FROM THE INSERT HANDLE, AND THE TIP OF THE INSERT WAS TRIED TO BE ATTACHED TO THE BOLT INSERTION HOLE OF THE PLATE, BUT IT COULD NOT BE CONNECTED UNLESS IT WAS PUSHED HARD. THE SURGEON COMMENTED THAT THE TIP OF THE INSERT MIGHT BE DEFORMED OR THERE MIGHT BE A PROBLEM WITH THE PLATES. ALTHOUGH THERE WAS A GAP OF A FEW MILLIMETERS BETWEEN THE BLACK SCREW OF THE INSERT AND THE INSERT HANDLE, 2-HOLE PLATE MANAGED TO BE CONNECTED, AND THE SURGERY WAS COMPLETED WITHIN THIRTY (30) MINUTES DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A FEMORAL NECK SYSTEM PLATE 1 HOLE. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606960 FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE APPLIANCE, FIXATION, NAIL KTT SYNTHES GMBH 60P7462 07612334089687

    Patients

    Seq Age Sex Outcome Treatment
    1 INS F/INSERTION HANDLE| INSERT HANDLE| PL 2HO F/FEM NECK SYST TAN