BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM

    MDR report key: 4806196 · Received May 29, 2015

    Report

    Report Number
    0009610622-2015-00276
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    May 9, 2015
    Report Date
    May 10, 2015
    Manufacturer
    STRYKER TRAUMA KIEL (MDR)
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE IMPLANTED, LABEL ONLY WILL BE RETURN

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REFERRING TO THE PRODUCT INQUIRY THE GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM IS STATED TO BE THE SUBJECT PRODUCT. A FURTHER ASSOCIATED PRODUCT (THE LABEL OF IT) WAS MENTIONED, BUT WAS NOT PART OF THE PRODUCT INQUIRY. NEVERTHELESS, AS THE ISSUE IS ABOUT AN ALLEGED MIX-UP OF LABELS WITH BOTH PRODUCTS INVOLVED, THE MANUFACTURING DOCUMENTS OF THE (ASSOCIATED) NAIL KIT HAVE ALSO BEEN REVIEWED, IN PARTICULAR THE PACKAGING / LABELING DOCUMENTS; NO DEVIATION WAS FOUND. LIKEWISE, REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED GUIDE WIRE REVEALED NO CONSPICUITIES IN PARTICULAR REGARDING THE PACKAGING / LABELING DOCUMENTS. THE TOTAL QUANTITY OF LABELS USED FOR EACH PRODUCT IN QUESTION (NAIL KIT AND GUIDE WIRE) WAS VERIFIED; NO DEVIATION WAS FOUND. BOTH PRODUCTS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. EVALUATION REVEALED THAT THE REPORTED EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE PRODUCT RESP. BY A MISLABELING BY THE MANUFACTURER. BOTH ITEMS GUIDE WIRE AND NAIL KIT WERE PACKED AT THE SAME LOCATION; THE TIME INTERVAL BETWEEN BOTH PACKAGING PROCESSES WAS ONE MONTH. THUS, WE EXCLUDE A MIX-UP DURING THE PACKAGING PROCESS. BASED ON THE FACT, THAT BOTH ITEMS (GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM / CAT # (B)(4), LOT CODE K07C792 AND TROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM X 130° / CAT # (B)(4), LOT CODE KU50752) WERE DELIVERED TO THE COMPLAINING HOSPITAL ON (B)(6) 2015, A MIX-UP OF LABELS IN THE HOSPITAL APPEARS MORE LIKELY THAN AN ERROR DURING THE PACKAGING PROCESS, WHICH IS PRECISELY DOCUMENTED WITHOUT INDICATION OF DEVIATION. CONSIDERING THE ABOVE OBSERVATIONS ANY REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS WAS DISPENSABLE IN THIS CASE AND ANY POTENTIAL CORRECTIVE / PREVENTIVE ACTIONS HAVE BEEN DEEMED UNNECESSARY. THE EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE PRODUCT; THE ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE NURSE AT THE HOSPITAL : "WE HAD AN ISSUE WITH SINGLE-USE DEVICES LABELS BETWEEN A GUIDE-WIRE DIAM 3 L100 AND A NAIL DIAM 11 X 180 X 130° (GAMMA NAIL). THE PHARMACIST, WHO WAS PRESENT IN THE OPERATING ROOM, COULD OBSERVE THAT THERE WAS A MISTAKE AND PUT A NOTE ON THE ORDER FORM. ON THE OUTTER LABEL, IT WAS INDEED A GUIDE-WIREL BUT ON THE INNER (PATIENT) LABEL, IT WAS FOR A GAMMA NAIL (REF (B)(4) LOT # KU50752).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE NURSE AT THE HOSPITAL : "WE HAD AN ISSUE WITH SINGLE-USE DEVICES LABELS BETWEEN A GUIDE-WIRE DIAM 3 L100 AND A NAIL DIAM 11 X 180 X 130 GAMMA NAIL). THE PHARMACIST, WHO WAS PRESENT IN THE OPERATING ROOM, COULD OBSERVE THAT THERE WAS A MISTAKE AND PUT A NOTE ON THE ORDER FORM. ON THE OUTTER LABEL, IT WAS INDEED A GUIDE-WIREL BUT ON THE INNER (PATIENT) LABEL, IT WAS FOR A GAMMA NAIL (REF (B)(4) LOT # KU50752).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347959 GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL (MDR) K07C792

    Patients

    Seq Age Sex Outcome Treatment
    1 Other