Model Number 210110 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/16/2020 |
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
|
Setting up for a mako pka case, dr was assembling the mako leg positioner onto the bed and patient leg.When dr placed the boot & patient leg into the sled- the leg positioner sled would not hold the weight of the leg in position.The leg would keep falling lateral whenever the leg was let go by the surgeon.No delays to surgery, surgery was completed by assistant manually holding the leg in place to support it.
|
|
Manufacturer Narrative
|
Reported issue.Setting up for a mako pka case, dr was assembling the mako leg positioner onto the bed and patient leg.When dr placed the boot & patient leg into the sled- the leg positioner sled would not hold the weight of the leg in position.The leg would keep falling lateral whenever the leg was let go by the surgeon.No delays to surgery, surgery was completed by assistant manually holding the leg in place to support it.Product inspection : product inspection could not be performed as the product was not made available for evaluation within 60 days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the product becomes available for inspection.Product history review.Review of the device history records indicate 25 devices were manufactured and accepted into final stock on 12/02/2016.No non-conformances were identified during inspection.Complaint history review.A review of complaints related to p/n 210110, lot 19400616 shows 3 additional complaint(s) related to the failure in this investigation.Conclusion.The alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.¿.
|
|
Event Description
|
Setting up for a mako pka case, dr was assembling the mako leg positioner onto the bed and patient leg.When dr placed the boot & patient leg into the sled- the leg positioner sled would not hold the weight of the leg in position.The leg would keep falling lateral whenever the leg was let go by the surgeon.No delays to surgery, surgery was completed by assistant manually holding the leg in place to support it.
|
|
Manufacturer Narrative
|
Reported issue.Setting up for a mako pka case, dr was assembling the mako leg positioner onto the bed and patient leg.When dr placed the boot & patient leg into the sled- the leg positioner sled would not hold the weight of the leg in position.The leg would keep falling lateral whenever the leg was let go by the surgeon.No delays to surgery, surgery was completed by assistant manually holding the leg in place to support it.Product inspection : functional inspection confirms the ball moves when tested with a known good boot assembly when in the locked position, confirming the alleged failure.Product history review.Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 12/02/2016.No non-conformances were identified during inspection.Complaint history review a review of complaints related to p/n 210110, lot 19400616 shows 3 additional complaint(s) related to the failure in this investigation.Conclusion the alleged failure was confirmed via inspection.No additional investigation or specific actions are required.¿.
|
|
Event Description
|
Setting up for a mako pka case, dr was assembling the mako leg positioner onto the bed and patient leg.When dr placed the boot & patient leg into the sled- the leg positioner sled would not hold the weight of the leg in position.The leg would keep falling lateral whenever the leg was let go by the surgeon.No delays to surgery, surgery was completed by assistant manually holding the leg in place to support it.
|
|
Search Alerts/Recalls
|