EXACTECH, INC. GLND KWIRE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number GLND KWIRE |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2022 |
Event Type
malfunction
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Event Description
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As reported, during surgical procedure the 2.0mm k-wire fractured during glenoid reaming with 38mm cannulated reamer.Approx.1.5cm of the distal tip fractured.Fractured tip was unable to be retrieved.Standard glenoid based plate inserted without issue.The reverse total shoulder procedure continued without incident.All glenoid components (glenoid baseplate/screws / glenosphere) implanted without issue.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Device is not returning, sent to pathology at hospital.
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Manufacturer Narrative
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Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Manufacturer Narrative
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(h3) the broken device reported may have been the result of applying a bending moment to the wire which led to fracture of the tip.However, this cannot be confirmed because the component was not returned for evaluation.Section h11: the following sections have corrected information: (h6) component code: 829, guide.
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