BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-WIRE GAMMA Ø3,2X450 MM

    MDR report key: 6239371 · Received January 10, 2017

    Report

    Report Number
    0009610622-2017-00009
    Event Type
    Injury
    Date Received
    January 10, 2017
    Date of Event
    November 28, 2016
    Report Date
    June 2, 2017
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Removal / Correction Number
    RA 2016-169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISPOSITION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    REFERRING TO THE PRODUCT INQUIRY ALL REPORTED ITEMS (INCLUDING THE K-WIRE GAMMA Ø3,2X450 MM, CAT # 12106450S, LOT CODE K09F026) ARE CONSIDERED PRIMARY PRODUCTS. THE PRODUCTS WERE NOT AVAILABLE TO STRYKER. HOWEVER, NO PRODUCT MALFUNCTION WAS REPORTED; THE ISSUE IS ABOUT AN INFECTION, WHEREAS ACCORDING TO THE SALES REP THE IDENTIFIED MICROORGANISM WAS (B)(6) (TYPICAL HOSPITAL PATHOGEN) AND THE INFECTION WAS LOCALIZED AT THE INCISION AT THE RIGHT HIP. THIS MEANS A SUPERFICIAL SKIN INFECTION AND NO INFECTION E.G. OF THE HIP JOINT. ACCORDING TO THE SALES REP THE INFECTION WAS CLINICALLY HEALED AND NO IMPLANTS WERE REMOVED. REVIEW OF THE DEVICE HISTORY RECORDS (INCLUDING THE STERILIZATION CERTIFICATE) OF THE REPORTED K-WIRE REVEALED NO CONSPICUITIES. THE ITEM WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. NEVERTHELESS, THIS K-WIRE (LOT CODE K09F026) WAS AFFECTED BY RA 2016-169 WHICH WAS INITIATED BY 3 CUSTOMER COMPLAINTS REGARDING K-WIRE POUCHES WITH MISSING SEALING AT ONE END, FOLLOWED BY (B)(4). HOWEVER, A MISSING SEALING OF THE POUCH IS OBVIOUS AFTER REMOVAL FROM THE OUTER CLEAR TUBE. SINCE THE IDENTIFIED MICROORGANISM WAS (B)(6) (TYPICAL HOSPITAL PATHOGEN) AND THE INFECTION WAS LOCALIZED AT THE INCISION AT THE RIGHT HIP AND ADDITIONALLY, THE SALES REP CONFIRMED ON REQUEST, THAT IN THIS CASE THE STERILE BARRIER OF THE PACKAGE WAS NOT COMPROMISED, A RELATIONSHIP BETWEEN THE REPORTED INFECTION AND THE K-WIRE (LOT CODE K09F026) CAN BE EXCLUDED. ALL AVAILABLE INFORMATION WAS PRESENTED TO A CONSULTING HEALTH CARE PROFESSIONAL FOR REVIEW. HIS COMMENT: ¿IT CAN BE CONCLUDED WITH ABSOLUTE CERTAINTY THAT THE REPORTED TYPICAL HOSPITAL PATHOGEN ¿(B)(6)¿ DID NOT ORIGINATE FROM THE ORIGINALLY PACKED PRODUCTS REPORTED, BUT WAS RATHER CAUSED BY POOR HYGIENE IN THE HOSPITAL.¿ THUS, A REVIEW OF THE EVENT IN LINE WITH ¿DQF 13-002 INFECTION COMPLAINTS CHECKLIST INVESTIGATOR V4¿ WAS DEEMED NOT NECESSARY. THE EXPIRATION DATE OF THE STERILE K-WIRE REPORTED WAS NOT EXCEEDED. NO NON-CONFORMANCE REGARDING THE STERILE BARRIER OF THE K-WIRE PACKAGING WAS FOUND ACCORDING TO THE SALES REP.

    Description of Event or Problem · 1

    INFECTION WAS REPORTED AFTER (B)(6) 2016 PRIMARY SURGERY. HIP (SIDE UNKNOWN). PATIENT WAS NOT REVISED, COMPONENTS WERE NOT REMOVED.

    Description of Event or Problem · 1

    INFECTION WAS REPORTED AFTER (B)(6) 2016 PRIMARY SURGERY. HIP (SIDE UNKNOWN). PATIENT WAS NOT REVISED, COMPONENTS WERE NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20405 K-WIRE GAMMA Ø3,2X450 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K09F026

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention