Catalog Number 207084 |
Device Problems
Contamination /Decontamination Problem (2895); Non Reproducible Results (4029)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 06/05/2019 |
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
|
Impactor is consistently containing bio burden after sterilization.Case type: tha.Surgical delay = 15 minutes.
|
|
Manufacturer Narrative
|
Reported event: it was reported that the impactor (straight cup reamer handle) is consistently containing bio burden after sterilization.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Product history review: review of device history records indicated that 100 devices were manufactured under lot 06081215 and accepted into final stock on (b)(6) 2016.No non-conformances were identified during inspection.Complaint history review a review of complaints in catsweb and trackwise related to (b)(4),lot 06081215 shows no additional complaints related to the failure in this investigation.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no ncs or capas associated with the product and failure mode reported in this event.H3 other text : device not returned.
|
|
Event Description
|
Impactor is consistently containing bio burden after sterilization.Case type: tha.Surgical delay: =15 minutes.
|
|
Search Alerts/Recalls
|