Model Number N/A |
Device Problems
Fracture (1260); Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/21/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during a shoulder arthroplasty, the pin became jammed in the pin driver and subsequently fractured.The pin could not be removed.No adverse events were reported as a result of this malfunction.
|
|
Manufacturer Narrative
|
(b)(4).D10 - concomitant devices - vanguard knee shortquick-release drill catalog #: 32-486259.Lot #: ni g2 - report source - foreign: event occurred in canada.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2023-01007.H3 other text : investigation.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
Upon reassessment of the reported event, it was determined that this event will be reported under manufacturing report number 0001825034-2023-02166.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|