Catalog Number 405809 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.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 broke when trying to unscrew the top.No adverse event has been reported as a result of the malfunction.
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Manufacturer Narrative
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D4: udi# (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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No additional event information is available at the time of this report.
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Manufacturer Narrative
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Upon receipt of additional information, it has been determined that this device malfunction did not cause or contribute to the any serious reported event in the past.The initial report was forwarded in error and should be voided.
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Event Description
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Upon receipt of additional information, it has been determined that this device malfunction did not cause or contribute to the any serious reported event in the past.The initial report was forwarded in error and should be voided.
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Event Description
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No additional event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, d10, g4, g7, h1, h2, h10 the following section was corrected: d4 (catalog number, lot number) 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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Search Alerts/Recalls
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