BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL ADAPTER S2

    MDR report key: 3071115 · Received April 22, 2013

    Report

    Report Number
    0009610622-2013-00214
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K113409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. INTERNAL INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE INSPECTION RECORDS FOR THE NAIL ADAPTER S2 (AND CONCOMITANT TISSUE PROTECTION SLEEVE) REVEALED NO DISCREPANCIES. THE LOT WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE NAIL ADAPTER S2 HAD BEEN IN USE FOR MORE THAN 3.5 YEARS WE PRE-SUPPOSE THAT THE DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. THUS, WE EXCLUDE DEVIATIONS IN MATERIAL AND MANUFACTURING. SIGNIFICANT IMPACTS ON THE DEVICE BY A SOLID INSTRUMENT (HAMMER) CAUSED IN MATERIAL DISPLACEMENT. SUCH A MATERIAL DEFORMATION IS ALSO VISIBLE AT THE LOWER RIM OF THE OBLIQUE BORE HOLE WHICH DECREASED THE PORT DIAMETER SO THAT THE TISSUE PROTECTION SLEEVE DID NOT PASS THROUGH THE INTENDED HOLE. THE FOUND TRACES ON THE NAIL HANDLE ARE THE RESULT OF UNINTENDED HIGH FORCES HAVING BEEN APPLIED TO THE NAIL ADAPTER. DUE TO THIS KIND OF DAMAGE THE INSTRUMENTS COULD NOT BE DISSEMBLED AFTER THE SURGERY. OP-TECHNIQUE AS WELL AS IFU RECOMMENDS CHECKING FUNCTIONALITY WITH CORRESPONDING COMPONENTS PRIOR TO SURGERY. THUS, IT IS NOT ACCESSIBLE THAT THIS KIND OF DAMAGE HAD NOT BEEN NOTICED PRIOR TO SURGERY RESPECTIVELY DURING FORMER SURGERIES. THE EXACT ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED BUT APPEARANCE AND EXTENT OF DAMAGE INDICATE THAT THE RETURNED NAIL ADAPTER HAD BEEN USED DEVIATED FROM SURGICAL TECHNIQUE AND BASED ON THE AVAILABLE INFORMATION WE REGARD THIS EVENT AS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE EXTRACTION OF A S2 TIBIAL NAIL, THE TISSUE PROTECTION SLEEVE GOT BLOCKED ON THE PROXIMAL END OF THE NAIL ADAPTER. THE SURGERY WAS COMPLETED AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE EXTRACTION OF A S2 TIBIAL NAIL, THE TISSUE PROTECTION SLEEVE GOT BLOCKED ON THE PROXIMAL END OF THE NAIL ADAPTER. THE SURGERY WAS COMPLETED AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171625 NAIL ADAPTER S2 INSTRUMENT HSB STRYKER OSTEOSYNTHESIS-KIEL K268764

    Patients

    Seq Age Sex Outcome Treatment
    1