Model Number N/A |
Device Problems
Material Disintegration (1177); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Udi#: (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during a right total shoulder arthroplasty, while sizing the glenoid (using the access quick-connect guide handle) and moving it around in the shoulder, the pin and spring came out the back of it.There was no impact on the patient as another instrument from a backup tray was used thereafter.No pieces of the instrument fell into the patient's wound.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the device is disassembled.The etch on the device has worn and is very light.The plunger of the quick connect guide has fractured at the tip.The tip of the plunger was not returned.This instrument has a possible field age around 3 years.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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