BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC

    MDR report key: 19230898 · Received May 2, 2024

    Report

    Report Number
    8030965-2024-05703
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    10886982075192
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. H11 ADDITIONAL NARRATIVE: H3, H4, H6: 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 HISTORY REVIEW (DHR): MANUFACTURING LOCATION: SUPPLIER- BACHLER FEINTECH / MONUMENT. MANUFACTURING DATE: 17-NOV-2021. PART NUMBER: 03.130.010, STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC. LOT NUMBER: 97P6252 (NON-STERILE). LOT QUANTITY: 92. EIGHT PIECES WERE SCRAPPED IN CELL FOR DESTRUCTIVE TESTING. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE EIGHT PIECES NOTED. INSPECTION SHEET / INCOMING INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. CERTIFICATE OF COMPLIANCE RECEIVED FROM BACHLER FEINTECH WAS REVIEWED AND DETERMINED TO BE CONFORMING. HEAT TREAT INSPECTION CERTIFICATE SUPPLIED TO BACHLER FROM HARTEREI SCHMID AG WAS REVIEWED AND DETERMINED TO BE CONFORMING. INSPECTION CERTIFICATE SUPPLIED TO BACHLER FROM L. KLEIN SA (FOR RAW MATERIAL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATION OF ANALYSIS SUPPLIED BY IONBOND WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATE OF COMPLIANCE SUPPLIED BY GENERAL MACHINE 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 OR INSPECTION OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. E3: REPORTER IS A J&J EMPLOYEE. H3, H6: 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. H6 MEDICAL DEVICE PROBLEM CODE (A27) USED TO CAPTURE REPORTABLE MALFUNCTION RELATED TO RECALL. H9 FDA CORRECTION/ REMOVAL REPORTING NO.: 3008812560-04/23/2024-001-R. 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 REPORTED THAT ON AN UNKNOWN DATE, THE SALES CONSULTANT RECEIVED A VA TITANIUM LOCKING HAND INSTRUMENT FROM THE COMPANY. THE STARDRIVE SCREWDRIVER SHAFT THAT CAME WITH THE SET DOES NOT FIT THE UNKNOWN 1.3 CORTEX LOCKING NOR THE UNKNOWN 1.5 CORTEX VA LOCKING. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458158 STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC SCREWDRIVER HXX SYNTHES GMBH 97P6252 10886982075192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown