BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANSSON TWIN HOOK 90MM, OMEGA PLUS TI

    MDR report key: 2990072 · Received March 5, 2013

    Report

    Report Number
    0008031020-2013-00038
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED INCIDENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. HOWEVER, THE SURGEON REPORTED THAT HE THOUGHT THE PATIENTS' BONE QUALITY INFLUENCED. THEREFORE, A PATIENT DEVICE INTERFACE ISSUE COULD NOT BE EXCLUDED. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. PLEASE NOTE THAT MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE 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

    DURING OMEGA TWIN HOOK SURGERY, THE SURGEON PUSHED THE HOOK OUT BY THE T-HANDLE. AFTERWARDS, WHEN THE SURGEON CONFIRMED BY X-RAY, THE HOOK WAS PUSHED OUT WITHOUT CURVING. THEREFORE, THE SURGEON PULLED BACK THE HOOK AND INSERTED THE NEW PIN. HOWEVER, THE NEW PIN WAS ALSO PUSHED OUT, WITHOUT CURVING. THE SURGERY WAS COMPLETED. THE SURGEON THINKS THAT THE PATIENT'S BONE QUALITY INFLUENCED THE SURGERY.

    Description of Event or Problem · 1

    DURING OMEGA TWIN HOOK SURGERY, THE SURGEON PUSHED THE HOOK OUT BY THE T-HANDLE. AFTERWARDS, WHEN THE SURGEON CONFIRMED BY X-RAY, THE HOOK WAS PUSHED OUT WITHOUT CURVING. THEREFORE, THE SURGEON PULLED BACK THE HOOK AND INSERTED THE NEW PIN. HOWEVER, THE NEW PIN WAS ALSO PUSHED OUT, WITHOUT CURVING. THE SURGERY WAS COMPLETED. THE SURGEON THINKS THAT THE PATIENTS' BONE QUALITY INFLUENCED THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93133 HANSSON TWIN HOOK 90MM, OMEGA PLUS TI INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other