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Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
Report source: foreign: country: (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.
Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02342, 0001825034-2020-02343, 0001825034-2020-02344, 0001825034-2020-02345, 0001825034-2020-02346, 0001825034-2020-02347.
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Event Description
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It was reported upon inspection at the incoming warehouse, there was debris in the sterile package.
No patient involvement.
No additional information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
The following sections were updated/corrected: updated: b4, b5, d4, d10, g4, h2, h3, h4, h6.
Complaint sample was evaluated and the reported event was confirmed.
Evaluation of the returned products confirmed foreign debris is present inside the sterile packaging and the sterile packaging remains sealed.
The reported event is confirmed.
Device history record (dhr) was reviewed and no discrepancies were found.
The likely condition of the devices when it left zimmer biomet is non-conforming to specification.
The root cause of the reported event is the operator not following the work instructions provided.
The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.
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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