Model Number N/A |
Device Problems
Device Inoperable (1663); Separation Failure (2547)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 02/27/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
It was reported the sales representative checked the set before delivering to another hospital for a case, and found that the contra angle screwdrivers did not work.One screwdriver was not turning smoothly, it is rough and hard to turn.The other screwdriver is getting harder to turn and after inserting a blade it could not be removed from the screwdriver.No patient involvement.
|
|
Manufacturer Narrative
|
Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The product identities were confirmed.Visual inspection of two 90 degree contra angle screwdrivers (part #24-1189, lot #580850) showed signs of moderate wear.One was sticking minimally and the other was tough to turn.Neither of the screwdrivers would release the blade head from the collet.The internal gears were found to be rusted and stripped.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the blade connection issues that were due to the supplier using blades, and not the min/max gage, to design the collet resulting in the collet failing the max gage inspection.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.
|
|
Search Alerts/Recalls
|