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

Catalog Number	111645
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2018
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
As reported: "event occurred in the operating room.The surgeon forgot to remove the femoral and tibial checkpoints from his first patient on (b)(6) 2018 before closing the skin.The [surgeon] remembered when closing the second patient on (b)(6) 2018 that he may have "forgot" to remove the checkpoints from the previous patient.An x-ray confirmed that the two checkpoints remained in, and the first patient was immediately taken back to the operating room from post-op that same day in order to have them removed".Post op x-rays are not available.They do not want to release them to me.
Additional Manufacturer Narrative
Reported event: it was reported that as reported: "event occurred in the or.The surgeon forgot to remove the femoral and tibial checkpoints from his first patient on (b)(6) 2018 before closing the skin.The [surgeon] remembered when closing the second patient on (b)(6) 2018 that he may have forgot to remove the checkpoints from the previous patient.An x-ray confirmed that the two checkpoints remained in, and the first patient was immediately taken back to the or from post-op that same day in order to have them removed".Post op x-rays are not available.They do not want to release them to me.Product evaluation and results: no device inspection could be completed as the product was not available for evaluation.Product history review: review of the product history records indicate 1000 devices were manufactured under lot no 05162018-1 and accepted into final stock on 05/31/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111645, lot number 05162018-1 shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.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.
Event or Problem Description
As reported: "event occurred in the or.The surgeon forgot to remove the femoral and tibial checkpoints from his first patient on (b)(6) 2018 before closing the skin.The [surgeon] remembered when closing the second patient on (b)(6) 2018 that he may have forgot to remove the checkpoints from the previous patient.An x-ray confirmed that the two checkpoints remained in, and the first patient was immediately taken back to the or from post-op that same day in order to have them removed".Post op x-rays are not available.They do not want to release them to me.

• 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: 8025709
• Report Number: 3005985723-2018-00637
• Device Sequence Number: 16538673
• Product Code: OLO
• UDI-Device Identifier: 00848486029494
• UDI-Public: 00848486029494
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K143752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: 05162018-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 05/30/2019
• 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; Required Intervention
• Patient Age: 80 YR