Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/14/2020 |
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.(b)(6).
|
|
Event Description
|
It was reported the screw could not be gripped with the driver.The procedure was completed with other screws.No adverse events have been reported as a result of the malfunction.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional and/or corrected information.The previous report incorrectly reported a product return; this file is not associated with a product return.The complaint cannot be verified.Functional testing and inspections could not be performed due to the product not being returned and no photographs being provided.The most likely underlying cause cannot be determined.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.
|
|
Event Description
|
This follow-up report is being submitted to relay additional and/or corrected information.
|
|
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 was conducted on the screw and it showed significant damage at the cross-drive interface on the head of the screw.Functional testing was done for retention using a driver 01-7390 lot 048760 and bit 15-1196 lot 406650.The blade was inserted into the driver and the screw, then the assembly was lifted by the screw to verify the cross-drive feature could support the weight of the blade and driver.The screw failed this retention test.There will be no dhr review as the lot number remains unk.There are no indications of manufacturing defects.For this part (95-6104) and the previous one year (from the notification date) regarding retention failure, there is a complaint rate of 0.01% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is excessive force was applied beyond what the screw is designed to encounter on the screw head during use.Potential contributing factors are using a worn or incorrect blade and incorrect alignment of the blade and screw as well as the patient¿s bone density.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
|