Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item# 904759; lot# 068640; ziptight ankle syn fixation-ti ion ti.Foreign: event occurred in (b)(6).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: 0001825034-2020-04449.
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Event Description
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It was reported that during inspection, the piece was found open.Not patient involved.No surgery occurred.
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Manufacturer Narrative
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Upon visual evaluation, it has been determined that the sterile packaging remained intact and unopened.The initial report was forwarded in error and should be voided.
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Event Description
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Upon visual evaluation, it has been determined that the sterile packaging remained intact and unopened.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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