Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2: foreign ¿ japan multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00481.The product has been received by zimmer biomet and 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 the screw could not be inserted into the cup.The surgeon repeatedly drilled and checked the direction but could not insert the screw.Another screw was used to insert the cup.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4), this follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the first thread of the screw has been damaged.The head of the screw has wear markings.It is unknown if the damage occurred prior to or during the assemble attempts.Complaint confirmed based on the evaluation of the returned product damage.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.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 further information is available at the time of this report.
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Search Alerts/Recalls
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