ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME HANDPIECE, ELECTRICALLY-POWERED
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Calibration Problem (2890)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/05/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the unit was sent in for yearly calibration, it was determined that the device was observed to have inconsistent speed at evaluation.There was no harm, injury, or delay as there was no patient associated with this event.Due diligence is complete.No additional information is available.
|
|
Manufacturer Narrative
|
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: singapore.Review of the most recent repair record determined the motor speeds were out of specification on the low end.The motor, switch, bearings, spring seal, and reciprocating arm were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|
|
|