Model Number N/A |
Device Problems
Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(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.
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Event Description
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It was reported that incoming inspection member found deformed sterile package due to the impact to the stem during distribution.No patient harm or impact.Attempts to obtain additional information have been made; however, no more is available at this time.
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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 confirms that each of the returned product trays have scuff marks review of the device history records for this device identified following deviations or anomalies: (b)(4) was created at op # 950 for roughness being in 320-340 range.All parts were reworked and accepted.It is likely that the reported event occurred during shipping.However, a specific root cause cannot be determined.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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