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Model Number N/A |
Device Problems
Difficult to Remove (1528); Mechanical Jam (2983)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog #00430904300, base plate drill guide 1, lot # unknown.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03019.
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Event Description
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It was reported that during a workshop before a shoulder arthroplasty surgery, the surgeon tried moving the pin through the drill guide but was unable to do so.The pin became stuck inside the guide.The surgery was completed using a different device.No patient impact was reported, as there was no patient involvement.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection shows scratches and dings along the surface likely from prior use.This item has a piece of an unknown pin seized inside of the hole.The returned items do not contain an etch so identification cannot be determined.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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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