Model Number N/A |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/03/2018 |
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.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 that some stock was found to have a damaged inner pouch.
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Manufacturer Narrative
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(b)(4).The products were returned to biomet for evaluation and forwarded to a complaints and vigilance engineer for investigation who has reported that upon visual inspection it was confirmed that the parts had holes in inner sterile packaging, in alignment with the fins of the shell showing multiple abrasions, indicating that abrasion of the packaging at these points over time had resulted in the breach.A review of the mallory head ifu and packaging shows warnings regarding packaging inspection and damage.A review of the manufacturing history records confirms no abnormalities or deviations reported.The cause of the damage to the mallory head shells is confirmed as inadequate packaging design which has been re-mediated through capa (b)(4).No complaints have been received on the mallory-head packaging for this failure mode to date since.
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Event Description
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The inner pouches were damaged.
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Search Alerts/Recalls
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