|
Catalog Number 530.710 |
Device Problems
Output below Specifications (3004); Intermittent Energy Output (4025)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/15/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that the motor device had low power "doesn't have the strongest power" during an unspecified surgical procedure.During in-house engineering evaluation, it was determined that the device had low power, operated intermittently, the bearing was corroded and had a foreign substance on it.There were no reports of delays to the surgical procedure.There was patient involvement.It was unknown if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).
|
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device was operating intermittently, the bearing was corroded, had foreign debris and would not run.Therefore, the reported condition was confirmed.The assignable root cause was traced to improper maintenance.
|
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: during further investigation, it was noted that the device failed pretests for function of device and oscillation frequency with frequency meter.Corrected data; h10: it was reported in error that the device was functioning intermittently.D9: the date the device was returned for investigation was omitted in error.
|
|
Search Alerts/Recalls
|
|
|