Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).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.Conmitant medical products: thinflap system 24mm bent burr hole plate 30.6mm x.3mm, part# 19-1021, lot# ni.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source - (b)(6).
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Event Description
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It was reported that a screw fractured upon implantation during a cranial procedure.A plate was also scratched at the time of the screw fracture.New plates and screws were used to complete the procedure.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint is confirmed.A visual inspection confirmed that the tip of the screw is no longer present.There will be no dhr review as the lot numbers remain unknown.There are no indications of manufacturing defects.For this part (91-6704) and the previous one year (from the notification date) regarding the fracturing of this screw, there is a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the fracture is the application of excessive force beyond what the product is designed to encounter.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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