BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    VA LOCKSCR 2.7 HEAD 2.4 SELF-TAP L22 TA

    MDR report key: 12241932 · Received July 28, 2021

    Report

    Report Number
    8030965-2021-06168
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Report Date
    June 25, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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- THE PRODUCT WAS RETURNED TO US CQ FOR EVALUATION. THE US CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 TA THE SCREW WAS BROKEN AT THE NECK AND THE BROKEN PIECE WAS ALSO RETURNED. NO OTHER ISSUES WERE IDENTIFIED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 TA IN THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED 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 BROKEN CONDITION OF THE VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 TA. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS PROBABLE THAT THE VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 TA WAS BROKEN DUE TO THE UNINTENDED FORCES. 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 ==> STERILE: PART #: 04.211.022S LOT #: 8L05302 MANUFACTURING SITE: SELZACH SUPPLIER: (B)(4) RELEASE TO WAREHOUSE DATE: 09 APR 2021 EXPIRATION DATE: 01 APR 2031 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ----------------------------------------------------------- NON-STERILE: PART #: 04.211.022 LOT #: 95P1694 MANUFACTURING SITE: SELZACH SUPPLIER: (B)(4) RELEASE TO WAREHOUSE DATE: 10 MAR 2021 EXPIRATION DATE: N/A A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    OF THE 1 DEVICES REPORTED 0 DEVICES WERE RECEIVED FOR EVALUATION. 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

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134323 VA LOCKSCR 2.7 HEAD 2.4 SELF-TAP L22 TA SCREW, FIXATION, BONE HWC SYNTHES GMBH 8L05302

    Patients

    Seq Age Sex Outcome Treatment
    1