Model Number N/A |
Device Problems
Delivered as Unsterile Product (1421); Shipping Damage or Problem (1570); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is available to be returned to zimmer biomet for investigation.Establishment name: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.
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Event Description
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Before opening the last layer of aseptic packaging (still sealed), it was found that there was a hair on the oxford phase 3 anatomic arcom bearing.The doctor used the same type of product with different thickness of 3mm to complete the operation.The operation was delayed for 10 minutes.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.Then sales confirmed that root cause is due to the improper storage of the removed packaging and there was no issue with the product.Risk assessment: the reported event states foreign body found in with the device during the operation.The severity score associated with this failure mode is 4 ¿ permanent impairment of a body function or permanent damage to a body structure.The event also reports a delay of 10 minutes.The reported event is considered to be within the severity of the risk file.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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Event Description
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Before opening the last layer of aseptic packaging (still sealed), it was found that there was a hair on the oxford phase 3 anatomic arcom bearing.The doctor used the same type of product with different thickness of 3mm to complete the operation.The operation was delayed for 10 minutes.
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Search Alerts/Recalls
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