Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign- (b)(6).The 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.Product not returned.
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Event Description
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It was reported that during a procedure, the gripper ceased to grip the guide wire.
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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.Inspection of the returned device identified wear mark inside the 3.0mm hole.Functional check showed that 3.0 mm hole failed to securely grip the wire.However, 2.4 mm hole securely grips the wire.Dimensions taken on the device was within specifications.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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