BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X320MM X 130°

    MDR report key: 4220598 · Received November 3, 2014

    Report

    Report Number
    0009610622-2014-00612
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 13, 2014
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE NAIL KIT WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AN INVESTIGATION WAS NOT POSSIBLE DUE TO MISSING PRODUCT AND DUE TO MISSING INFORMATION. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL ACTIONS ARE IN PLACE. ACCORDING TO (SPARSE MEDICAL BACKGROUND DATA AVAILABLE) THE PATIENT HAD A HISTORY OF REPEATED NON-UNIONS. THE IFU INCLUDES SEVERAL WARNINGS, CONTRAINDICATIONS AND ADVERSE EFFECTS (IMPLANT DAMAGE, OBESITY, FULL WEIGHT BEARING, LONG IMPLANTATION TIME, NON-UNIONS). HOWEVER, THE DHR REVIEW REVEALED NO DEVIATIONS IN THE DESIGN AND MANUFACTURING. BASED ON THIS REVIEW A MANUFACTURING ISSUE CAN BE EXCLUDED. GENERAL TECHNICAL ASPECTS: THE ALLEGEDLY BROKEN IMPLANT IS TEMPORARY IMPLANT WHICH INEVITABLY WILL BE SUBJECT OF A FATIGUE FRACTURE IF THE STRESSES ON THE IMPLANT ARE TOO HIGH OR NOT CONSIDERABLY REDUCED DURING THE PERIOD OF IMPLANTATION. THIS COULD BE DESCRIBED AS A RACE BETWEEN BONY CONSOLIDATION / FRACTURE HEALING AND IMPLANT BREAKAGE. IF FRACTURE HEALING IS INSUFFICIENT MECHANICAL DAMAGE OF A LOAD-BEARING OR LOAD-SHARING DEVICE IS MORE LIKELY. THE AFFECTED IMPLANT IS DESIGNED TO WITHSTAND THE NORMAL LOADS DURING THE IMPLANTATION PERIOD, I.E., THE IMPLANT MUST NEITHER BE EXPOSED TO PEAK LOADS NOR TO CONTINUOUS STRESSES. ANOTHER PREREQUISITE FOR A SUCCESSFUL SUPPLY IS UNDISTURBED, NORMAL BONE HEALING. THIS STATE MUST BE ACHIEVED WITHIN A MEDICALLY RECOGNIZED AND CONFIRMED BY SCIENTIFIC ANALYSIS PERIOD (ABOUT 6 MONTHS), THAT THE BONE STRENGTH ALLOWS SIGNIFICANTLY INCREASING DISCHARGE OF THE TIME-FIXED IMPLANT MATERIAL. IN CASE THAT SUCH A SITUATION DOES NOT OCCUR, EXCEEDING OF THE FATIGUE STRENGTH IS TO BE EXPECTED AND THUS QUITE PREDICTABLE COMPLICATIONS. THE REVIEW OF THE DATABASE REVEALED THIS EVENT BEING THE ONLY ONE (OUT OF (B)(4) UNITS IN TOTAL) REGARDING THE REPORTED LOT-NO K089B30. WITH RESPECT TO THE ASPECTS DISCUSSED WE REGARD TO THIS CASE AS NOT DEVICE BUT RATHER PATIENT RELATED (REPEATED NON-UNIONS). IN THIS CASE IT COULD ONLY BE REFERRED TO AVAILABLE INFORMATION. WITH AVAILABLE INFORMATION THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE FILE WILL BE CLOSED FORMALLY AND CAN BE REOPENED WHEN SUBSTANTIVE INFORMATION OR THE ITEM(S) BECOME AVAILABLE. WE RESERVE THE RIGHT TO UPDATE THE INVESTIGATION AND CHANGE THE ROOT CAUSE. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED BY NURSE OF THE HOSPITAL, THAT THE NAIL IS BROKEN. THE IMPLANTATION WAS ON (B)(6) 2012. A 1ST REVISION WAS PERFORMED ON (B)(6) 2013 AND ANOTHER REVISION IN (B)(6) 2014.

    Description of Event or Problem · 1

    IT IS REPORTED BY NURSE OF THE HOSPITAL, THAT THE NAIL IS BROKEN. THE IMPLANTATION WAS ON (B)(6) 2012. A 1ST REVISION WAS PERFORMED ON (B)(6) 2013 AND ANOTHER REVISION IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702541 LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X320MM X 130° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K089B30

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention