Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).H3: the complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that the device was discovered to have missing components.Attempts to obtain additional information have been made; however, no more is available.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.Visual examination of the returned product/provided pictures identified signs of use.The returned shim was missing a ball bearing.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.This device is confirmed to have been a part of a capa investigation.Field actions were initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.These devices were subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that these devices were manufactured prior to this design change.The root cause is considered to be a previously addressed design issue.Complaint is confirmed based on the product evaluation.If any further information is received 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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