Catalog Number 5901-IS-3204 |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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As reported: "during final trialing of case, humeral insert trialing cracked during reduction.Just a small portion cracked off so no action was needed to support failure of trial.Outcome of the surgery was completed and no harmful circumstances." per email from rep, "trial did crack into two pieces, but both pieces were removed from the patient and surgical field.No delays, final trialing was complete at that point.".
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Manufacturer Narrative
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The reported event that humeral insert trial - 3 2mm x 4mm standard was alleged of 'instruments - peek - cracks / damage' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not returned.
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Event Description
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As reported: "during final trialing of case, humeral insert trialing cracked during reduction.Just a small portion cracked off so no action was needed to support failure of trial.Outcome of the surgery was completed and no harmful circumstances." per email from rep, "trial did crack into two pieces, but both pieces were removed from the patient and surgical field.No delays, final trialing was complete at that point.".
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Search Alerts/Recalls
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