Model Number 210080 |
Device Problem
Material Frayed (1262)
|
Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/27/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
|
|
Event Description
|
Black boot is fraying on the edges and cut open a surgeons glove.Patient was not under anesthesia.Case type: tka.
|
|
Manufacturer Narrative
|
Reported event: black boot is fraying on the edges and cut open a surgeons glove.Patient was not under anesthesia.Case type: tka.Product evaluation and results: visual inspection confirms carbon fiber splintering on the boot.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 06-14-2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210080, lot 201743060801 shows 5 additional complaints related to the failure in this investigation.(b)(4).Conclusions: the event was confirmed.Per (b)(4), preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.No additional investigation or specific actions are required.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.
|
|
Event Description
|
Black boot is fraying on the edges and cut open a surgeons glove.Patient was not under anesthesia.Case type: tka.
|
|
Search Alerts/Recalls
|