Model Number 7205000000 |
Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/30/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.Product return status: 2 device investigation types have not yet been determined.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.
|
|
Event Description
|
This report summarizes 2 malfunction events in which the device or cutting accessory fractured.2 events had no patient involvement; no patient impact.
|
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 2 events were previously reported during the reporting period; however, 1 previously reported event in this report should have been included under mfr report # 3015967359-2021-02332.1 previously reported event is included in this follow-up record.Product return status: 1 device investigation type has not yet been determined.
|
|
Event Description
|
This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had no patient involvement; no patient impact.
|
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 1 previously reported event is included in this follow-up record.Product return status 1 device was received.
|
|
Event Description
|
This report summarizes 1 malfunction event in which the device or cutting accessory fractured.- 1 event had no patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|