MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE); STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	111645
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Yesterday with a brand new surgeon, we went to take our final numbers for tka to see if we were balanced with actual implants and the numbers were way off so i said "grab green probe" and we did the femur check point and it was all good then went to tibia check point and it was off like 6mm so i said the array must have been bumped or check point so i said "those numbers might not be accurate" and asked surgeon to see how it felt and he said it looked good so i said "ok you can remove everything "and they missed the checkpoints case type: tka.
Additional Manufacturer Narrative
Reported event: it was reported that the user left the checkpoints in the patient even after mps's instruction to remove them.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: product history review was not performed as the lot number was not provided.Complaint history review: complaint history review was not performed as the lot number was not provided.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.Product was unavailable for inspection as the product was not returned.
Event or Problem Description
Yesterday with a brand new surgeon, we went to take our final numbers for tka to see if we were balanced with actual implants and the numbers were way off so i said grab green probe and we did the femur check point and it was all good then went to tibia check point and it was off like 6mm so i said the array must have been bumped or check point so i said those numbers might not be accurate and asked surgeon to see how it felt and he said it looked good so i said ok you can remove everything and they missed the checkpoints case type: tka.

• Brand Name: FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE)
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8160715
• Report Number: 3005985723-2018-00738
• Device Sequence Number: 2203008
• Product Code: OLO
• UDI-Device Identifier: 00848486029494
• UDI-Public: 00848486029494
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K143752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 111645
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other