Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.The investigation is in process.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 by the hospital that when removing the peel-off seal it was recognized that a part of about 1 cm wasn't welded with the plastic packaging.Subsequently, the sterility could not be ensured, therefore the implant wasn't used.
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Event Description
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It was reported by the hospital that when removing the peel-off seal it was recognized that a part of about 1 cm wasn't welded with the plastic packaging.Subsequently, the sterility could not be ensured, therefore the implant wasn't used.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The reported event (damaged pouch) has been confirmed through visual inspection of the returned packaging, which confirms the inner sterile barrier (pouch) is damaged.The likely condition of the device when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be transit damage.Device history record (dhr) was reviewed and no discrepancies were found.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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Search Alerts/Recalls
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