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Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
Event Type
malfunction
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Event Description
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It was reported during circulation that the sterile package of the products was damaged.It was reported that no additional information is available.
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Manufacturer Narrative
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(b)(4).D10: 51-100040 tprlc 133 fp type1 pps so 4.0 6644495, 51-105130 tprlc xr t1 pps 13x146mm 6883665.G2: foreign: japan.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02476, 0001825034-2023-02478.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Updated: d9, g3, g6, h2, h3, h6 visual evaluation of the returned product/provided photos identified damage to the sterile packaging (blister).Sterility has not been compromised.The reported event has been confirmed by evaluation of the returned product and provided photos.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.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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No additional event information to report at this time.
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Search Alerts/Recalls
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