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Model Number HC343 |
Device Problem
Component Misassembled (4004)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint number (b)(4).Patient identifier, age and date of birth unknown / not provided, patient sex unknown / not provided, weight unknown / not provided, date of the event unknown / not provided, email address was not provided.
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Event Description
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It was reported that the healing collar hc343 - (gingiva former) could not be screwed and it could not be placed, the tip of the screw does not seat.
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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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Zimmer biomet complaint number (b)(4).A heal collar 3.5x4.5, 3mm (hc343) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the devices was the same day.Pictures was provided by the customer.Seems to have slight thread damage.Device history record (dhr) review was completed for the subject lot number (2019060896).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019060896) for similar event and no other complaint was identified.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.
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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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Zimmer biomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.D10: device availability.G4: date received by manufacturer.G7: type of report, follow-up number.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: event problem and evaluation codes.H10: additional narrative.Three heal collar 3.5x4.5, 3mm (3 x hc343) were returned for investigation.Visual evaluation of the as returned products identified worn markings due to usage around body and the threads.Functional testing was performed for the returned products with an in-house stock device and one seated as intended.Two did not seat.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the devices was the same day.Pictures were provided by the customer.Seems to have slight thread damage.Device history record (dhr) review was completed for the subject lot number (2019060896).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019060896) for similar event and no other complaint was identified.Based on the available information, device malfunction did not occur and the reported event is unconfirmed, however malfunction occurred with the other two and the reported event is confirmed.
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Search Alerts/Recalls
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