|
Model Number N/A |
Device Problem
Dull, Blunt (2407)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/31/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Zimmer biomet complaint (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.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source - (b)(6).
|
|
Event Description
|
It was reported that the screws would not enter the bone during a cranial procedure.No adverse events were reported as a result of the malfunction.
|
|
Event Description
|
This follow-up report is being submitted to relay additional information.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The complaint is confirmed.A visual inspection found that the screw heads show signs of use and the tips of the screws show signs of wear from a failed insertion attempt.Functional testing was completed by attempting to insert the screws into a piece of white oak wood.The screws would not enter the wood when the insertion attempt was made.The dhr will not be reviewed as the lot number remains unknown.There are no indications of manufacturing defects.For this part (95-6104) and the previous one year (from the notification date) regarding the failure of insertion of the screws, (b)(4).The most likely underlying cause of the damage to the screws is the application of excessive force beyond what the screw is designed to encounter.The patient's bone density may have also been a factor.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
|
|
|