Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: 912082 jgrknt 1.0mm mini 3-0 ndls 554590; 912082 jgrknt 1.0mm mini 3-0 ndls 537470.Foreign- (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04457, 0001825034 - 2020 - 04458.
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Event Description
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It was reported that during the surgery, the sutures of the juggerknot broke when the surgeon pulled the sutures after he inserted the anchors into the burr hole.There was a surgical delay of 15 to 30 minutes for preparing an alternate device.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned products identified no damages to the main portion of the products (handles).Inspection confirms the returned sutures have been torn/broken.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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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Search Alerts/Recalls
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