Model Number 112240 |
Device Problems
Mechanical Problem (1384); Misassembled (1398); Use of Device Problem (1670); Misassembly by Users (3133)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/06/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
As part of the 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
|
Pelvic array and pelvic array clamp got cross threaded and need to be replaced.Case type: tha.
|
|
Manufacturer Narrative
|
Reported event: pelvic array and pelvic array clamp got cross threaded and need to be replaced.Product evaluation and results: visual inspection.The product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: review of the device history records indicate 31 devices were manufactured and accepted into final stock on 10/31/2011.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112240, lot number 19010811 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 nc and capa associated with the product and failure mode reported in this event.H3 other text : device not returned.
|
|
Event Description
|
Pelvic array and pelvic array clamp got cross threaded and need to be replaced.Case type: tha.
|
|
Search Alerts/Recalls
|