Model Number N/A |
Device Problems
Difficult to Insert (1316); Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001822565 - 2019 - 00163.(b)(4).Concomitant medical products: 47430902501 pin 2.5 mm diameter lot 63662169.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 shoulder arthroplasty procedure, the guide pin got stuck in the guide during use and was unable to be removed.The surgery was completed with another device without significant delay.There were no patient consequences as a result of the malfunction.No further information available.
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Manufacturer Narrative
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(b)(4).Examination of the returned pin along with the guide confirms the reported inability to separate the instrumentation.The devices are seized together with indications of wear and galling.It is confirmed the device(s) meet their dimensional specifications.Review of device history records was not possible as the necessary product/lot code combination(s) was not provided.Root cause was unable to 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.No further information provided at the time of this reporting.
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Event Description
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No further information provided at the time of this reporting.
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Search Alerts/Recalls
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