BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM

    MDR report key: 8875180 · Received August 8, 2019

    Report

    Report Number
    2939274-2019-59590
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Report Date
    July 12, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982053596
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DEVICE HISTORY LOT MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: 16-NOV-2018, PART NUMBER: 02.211.016, 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM , LOT NUMBER: H780122, LOT QUANTITY: 214. TWENTY PIECES WERE SCRAPPED IN CELL AT OP #10, MILL SHAFT THREAD/HEAD THREAD/FLUTE, AFTER BEING DROPPED. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE TWENTY PIECES NOTED. INSPECTION SHEET, IN PROCESS / INSPECT DIMENSIONAL / FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG WAS REVIEWED AND DETERMINED TO BE CONFORMING. 215 LABELS WERE PRINTED; 214 LABELS WERE USED ON PRODUCT AND 1 LABEL WAS USED ON THE PLL. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. THIS LOT MET ALL DIMENSIONAL AND VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW 25-JUL-2019: , 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. INVESTIGATION SUMMARY: INVESTIGATION SITE: MONUMENT, BACKGROUND: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INCOMING RECEIPT OF A REPLENISHMENT ORDER, THE VARIABLE ANGLE LOCKING SCREW SELF-TAPING WAS OBSERVED HAD AN EMPTY BAG WHEN THERE SHOULD HAVE BEEN ONE PART IN THE BAG. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. INVESTIGATION FLOW: LABELING AND PACKAGING VISUAL INSPECTION: AS RECEIVED: PACKAGE WAS RETURNED FOR EVALUATION AND EXAMINED. THERE IS NO SCREW INSIDE PACKAGE. PACKAGE WAS SEALED AND NO HOLES WERE VISIBLE IN PACKAGE. PACKAGE HAS THE CORRECT LOT AND PART NUMBER DOCUMENT/ SPECIFICATION REVIEW: 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. DIMENSIONAL INSPECTION: INVESTIGATION CONCLUSION: THE PRODUCT REVIEW SUPPORTS THE COMPLAINANT¿S DESCRIPTION OF THE COMPLAINT CONDITION THEREFORE THIS IS A CONFIRMED COMPLIANT. A REVIEW OF THE MANUFACTURING HISTORY FOR THIS PART DOES NOT SHOW ANY INDICATION THAT AN EMPTY PACKAGE EXISTED IN THE LOT, HOWEVER THE CAUSE OF THE COMPLAINT CONDITION WOULD BE DETERMINED AS OPERATOR ERROR IN WHICH THE OPERATOR DID NOT PLACE A PRODUCT IN THE PACKAGE DURING THE PROCESSING OF THIS LOT. NC # (B)(4) HAS BEEN INITIATED FOR THIS LOT. 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 PRODUCT CODE: HRS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INCOMING RECEIPT OF A REPLENISHMENT ORDER, THE BAG FOR THE VARIABLE ANGLE LOCKING SCREW SELF-TAPING WAS OBSERVED TO BE EMPTY WHEN THERE SHOULD HAVE BEEN ONE PART IN THE BAG. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A VARIABLE ANGLE LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668659 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.211.016 H780122 10886982053596

    Patients

    Seq Age Sex Outcome Treatment
    1