BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM

    MDR report key: 12109873 · Received July 2, 2021

    Report

    Report Number
    2939274-2021-03382
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Report Date
    February 24, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982152879
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: HRS. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: ONE PART, PART# 212.820-US // LOT# 79P2949, WAS RETURNED AT (B)(4) FOR EVALUATION AND IT WAS EXAMINED BY THE QUALITY ENGINEER. IT WAS CONFIRMED THAT THE PACKAGE IS EMPTY. THUS THIS COMPLAINT IS CONFIRMED. DOCUMENT/ SPECIFICATION REVIEW: THE RELEVANT DRAWING WAS REVIEWED. NO DISCREPANCIES OR ISSUES WERE NOTED. DATA REVIEW: DHR AND PACKAGING PROCESS WERE REVIEWED FOR LOT 79P2949. THE REVIEW OF THE PRODUCT BAG AND A REVIEW OF THE DHR CONFIRMED THE NONCONFORMANCE AS A MANUFACTURING NONCONFORMANCE GENERATED AT THE (B)(4) MANUFACTURING SITE. THE BAG WAS NOT OPENED BY THE EVALUATOR BUT IT WAS FOUND THAT THE GP2434 LABEL WAS APPLIED ON THE BAG, THE CORRECT INSERT WAS PLACED IN THE BAG AND IT WAS CONFIRMED NO PART WAS IN THE BAG. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PART SHOWS THE ORDER WENT THROUGH THE APPROPRIATE OPERATIONS TO BE PACKAGED: THROUGH THE PACKAGING PREPARATION OPERATION, THE FLOW INSPECT/PACK OPERATION, WHICH REFERENCES TO FOLLOW PIECE PACK WORK INSTRUCTION. A TUG TEST TO VERIFY SEAL OF THE PACKAGING IS PERFORMED ON THE FIRST 5 PIECES PER RELEVANT DOCUMENT, AND THE OPERATOR IS ALSO REQUIRED TO VERIFY "PROPER SEAL ON BAG" AND PART AND BOM COMPONENTS ARE PRESENT IN BAG. AT THE END OF THE RUN, LINE CLEARANCE/LABEL RECONCILIATION IS COMPLETED ON EVERY LOT PER PACKAGING LABEL LOG (PLL). THE PLL WAS REVIEWED WITHIN THE DHR AND NO ERRORS WERE IDENTIFIED ON THE LABEL RECONCILIATION FOR THIS LOT. PER PLL DATED 11/19/2020, A TOTAL OF 243 LABELS WERE PRINTED. 238 LABELS WERE USED ON PRODUCT; 1 LABEL WAS USED ON THE PLL AND 4 LABELS WERE DESTROYED. 238 GOOD PARTS ARE DOCUMENTED AT STEP 0060 ON ROUTER AND 2 PARTS WERE SCRAPPED AT THIS STEP. SCRAP CODE IS DB: ¿QUANTITY-COUNT UNDER¿ ASSIGNABLE CAUSE ANALYSIS: THE PARTS WERE PACKAGED ON SHARP PACKAGING MACHINE 0744. REVIEW OF THE MACHINE FOUND ROLL STOCK BAGS ARE PULLED THROUGH THE MACHINE WITH POWER DRIVE ROLLERS, A LABEL IS THEN APPLIED FOLLOWED BY A TIMED BLAST OF COMPRESSED AIR THAT OPENS THE BAG. THE OPERATOR THEN MANUALLY PLACES THE PART INTO THE BAG AS APPLICABLE PER BOM REQUIREMENTS AND THEN USES A FOOT PEDAL TO ACTIVATE THE SEALER TO SEAL THE BAG. FOR THE PACKAGE TO BE EMPTY, THE PLACEMENT OF PART IN THE BAG DID NOT OCCUR. AS THE OPERATOR IS REQUIRED TO VERIFY HIS/HER WORK AND MAKE SURE THAT THE PLL IS FILLED OUT CORRECTLY, THE ASSIGNABLE CAUSE IS FOUND TO BE MAN: OMISSION ERROR. A ONE PIECE PACKAGING VERIFICATION IS PERFORMED AT THE DHR REVIEW OPERATION. ASSIGNABLE CAUSE CONCLUSION: PER THE NC'S PROBLEM DESCRIPTION, 1 PART WAS FOUND NOT CONFORMING, NO PART IS PRESENT IN THE BAG. THE MAINTENANCE DATABASE WAS VERIFIED AND IT WAS CONFIRMED THAT MACHINE WAS FUNCTIONING CORRECTLY AND NO MAINTENANCE WORK ORDERS WERE ACTIVE ON OR AROUND 11/19/2020 WHEN THIS ORDER WAS PACKAGED. CAUSE OF THE NONCONFORMANCE IS DETERMINED TO BE MAN : OMISSION ERROR, IN WHICH THE OPERATOR MISSED VERIFICATION STEP. FINAL BOUNDING: BASED ON THE FINDINGS OF THE INVESTIGATION, IT WAS DETERMINED THAT THIS WAS AN ISOLATED INCIDENT AND BOUNDING IS LIMITED TO THIS PART ONLY. PRODUCT DISPOSITION THE REVIEW OF THE PART/BAG SUPPORTS THE COMPLAINANT¿S DESCRIPTION OF THE COMPLAINT CONDITION BUT BASED ON THE DHR REVIEW, ON THE PROCESS REVIEW AND THE PROCESS CONTROLS THAT ARE IN PLACE AND DOCUMENTED ABOVE (FOR PACKAGING PROCESS) IT WAS DETERMINED THAT THE THIS IS AN ISOLATED INCIDENT. THIS COMPLAINT IS CONFIRMED FROM A MANUFACTURING STANDPOINT. CONCLUSION: BASED ON THE DHR REVIEW, ON THE PROCESS REVIEW AND THE PROCESS CONTROLS THAT ARE IN PLACE AND DOCUMENTED ABOVE (FOR PACKAGING PROCESSES) IT WAS DETERMINED THAT THE NONCONFORMANCE IS LIMITED TO THIS ONE PART/BAG. THIS COMPLAINT IS CONFIRMED FROM A MANUFACTURING STANDPOINT. JBL-NR WAS OPENED TO ADDRESS THIS ISSUE. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 19-NOV-2020, PART NUMBER: 212.820, 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM, LOT NUMBER: 79P2949 (NON-STERILE), LOT QUANTITY: (B)(4). PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. A TWO-PIECE WEIGHT VARIANCE WAS RECORDED, FLOW INSPECT/PACK. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. A TOTAL OF (B)(4) LABELS WERE PRINTED. (B)(4) LABELS WERE USED ON PRODUCT; 1 LABEL WAS USED ON THE PLL AND 4 LABELS WERE DESTROYED. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. 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: COMPONENT PARTS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿ONE ENVELOPE FOR SCREW WAS RECEIVED EMPTY¿ DOES NOT INDICATE BREAKAGE OF THE SCREW. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE RELEVANT TO THE REPORTED COMPLAINT CONDITION. 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. 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 THE SEALED PACKAGE OF THE SCREW WAS DELIVERED EMPTY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004602 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 212.820 79P2949 10886982152879

    Patients

    Seq Age Sex Outcome Treatment
    1