Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2023 |
Event Type
malfunction
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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 follow-up mdr will be submitted.
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Event Description
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It was reported that when the stem was opened, a hole was found on the hard plastic sterile barrier.There was no patient involvement.It was reported no further information is available.
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Manufacturer Narrative
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(b)(4).H6 visual evaluation of the provided photo identified damage to the sterile packaging (blister).The provided photo depicts the packaging configuration used in manufacturing at the bridgend uk facility.Sterility has been compromised.The reported event has been confirmed by evaluation of the provided photo.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 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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