BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREADED GUIDE WIRE

    MDR report key: 7371508 · Received March 26, 2018

    Report

    Report Number
    0001825034-2018-02189
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    February 27, 2018
    Report Date
    July 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : 3.5MM CORTICAL SCREW SELF-TAPPING 18MM LENGTH CATALOG#: 47483501801 LOT#: 63096914, 3.5MM CORTICAL SCREW SELF-TAPPING 18MM LENGTH CATALOG#: 47483501801 LOT#: 63096914, 2.0X230MM THRD GUIDE WIRE STE CATALOG#:837820230 LOT#:L3CAR5A, 3.8X150MM CANN DRILL STE CATALOG#:214143100 LOT#:360140, 4.5X48MM CANN CORT LAG SCR ST CATALOG#: 851448148 LOT#:DPGBYN, 1.6X150MM BAY TIP GUIDE PIN ST CATALOG#:829516150 LOT#:425940, 2.0X150MM BAY TIP GDE WIRE ST CATALOG#:851417960 LOT#:558990, 2.0X150MM BAY TIP GDE WIRE ST CATALOG#:851417960 LOT#:438110, 4.5X46MM CANN CORT LAG SCR ST CATALOG#:851448146 LOT#:DPLBNF, 2.0X150MM BAY TIP GDE WIRE ST CATALOG#:851417960 LOT#:928010, NCB -DF PLATE RIGHT 5 HOLES CATALOG#: 02.02260.005 LOT#:2858464, NCB®, CORTICAL SCREW, 5.0 MM, 55 MM CATALOG#:0202150055 LOT#:2902634, NCB®, LOCKING CAP CATALOG#:0202150300 LOT#:4501985459, NCB®, LOCKING CAP CATALOG#:0202150300 LOT#: 4502046422, NCB®, LOCKING CAP CATALOG#:0202150300 LOT#:4501985459, NCB®, CANCELLOUS SCREW, ø 5.0 MM, 32 MM, 80 MM CATALOG#:0202152080 LOT#:2880878, NCB®, CANCELLOUS SCREW, ø 5.0 MM, 32 MM, 80 MM CATALOG#:0202152080 LOT#:2880878, NCB®, CANCELLOUS SCREW, ø 5.0 MM, 32 MM, 85 MM CATALOG#:0202152085 LOT#:2862528, 2.0X150MM BAY TIP GDE WIRE ST CATALOG#:851417960 LOT#:075390, 4.8/5.0MM FLAT WASHER STE CATALOG#:851426000 LOT#:314560, 5.0X85MM CANN CANC LAG SCR STE CATALOG#:850253085 LOT#:DPLBCL, 2.0X150MM BAY TIP GDE WIRE ST CATALOG#:851417960 LOT#:434610, NCB®, CANCELLOUS SCREW, ø 5.0 MM, 32 MM, 75 MM CATALOG#:0202152075 LOT#:2921553, NCB®, CORTICAL SCREW, 5.0 MM, 36 MM CATALOG#:0202150036 LOT#:2905902, NCB®, CORTICAL SCREW, 5.0 MM, 36 MM CATALOG#:0202150036 LOT#:2905902, NCB®, CANCELLOUS SCREW, ø 5.0 MM, 32 MM, 65 MM CATALOG#: 0202152065 LOT#: 2917894, 3.5 MM CORTICAL SCREW SELF-TAPPING 10 MM LENGTH CATALOG#: 47483501001 LOT#: 62509215, 3.5 MM CORTICAL SCREW SELF-TAPPING 10 MM LENGTH CATALOG#: 47483501001 LOT#: 62509215, ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES 49 MM LENGTH CATALOG#:47493500403 LOT#:63323953, 2.0X230MM THRD GUIDE WIRE STE CATALOG#: 837820230 LOT#: LK2AA5 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE THREADED TIP OF THE K-WIRE IS BROKEN OFF. EXTENSIVE WEAR AND DAMAGE CAN BE SEEN ON THE RETURNED PRODUCTS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4) REPORT SOURCE: FOREIGN. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXPIRATION DATE IS UNKNOWN. MANUFACTURING DATE IS UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF 2 K-WIRES FRACTURED DURING THE PROCEDURE. THE TIPS OF THE K-WIRES REMAIN INSIDE THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211905 THREADED GUIDE WIRE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ZIMMER BIOMET, INC. N/A L3CAR5A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 837820230 THREADED GUIDE WIRE, LOT LK2AA5| UNKNOWN PART/LOT, ACE CANNULATED SCREWS| 837820230 THREADED GUIDE WIRE, LOT LK2AA5| UNKNOWN PART/LOT, ACE CANNULATED SCREWS