Model Number N/A |
Device Problems
Positioning Failure (1158); Mechanical Jam (2983)
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Patient Problem
No Code Available (3191)
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Event Date 05/21/2019 |
Event Type
Injury
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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.Device evaluated by manufacturer? remains implanted.
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Event Description
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It was reported that during a surgery, the titanium button of the juggerloc did not fully zip down.However, after multiple attempts it was implanted successfully.There was a delay of 30 minutes as a result of this event.No additional patient consequences were reported.
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Manufacturer Narrative
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Corrected data: expiration date is jul 31, 2023 and not apr 6, 2023.Concomitant medical products: item# 110007345; jgrloc b2b rd ti sld drl kit; lot# 241040.Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device identified fraying and cuts in the sutures near the buttons.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04167.
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Event Description
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It was reported that during a surgery, the titanium button of the juggerloc did not fully zip down, leavikng several several millimeters of slack in the suture material.There was a delay of 30 minutes as a result of this event.No additional patient consequences were reported.
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Search Alerts/Recalls
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