MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL, CHECKPOINT, STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	111651
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon further information received on july 12,2023 "patient is doing well.Procedure was completed the following week and checkpoint was removed.", this event meets the criteria of a serious injury due to medical intervention.Reported event: an event regarding user error involving a mako checkpoint was reported.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of the device history records cannot be conducted as the lot/serial number was not reported.Complaint history review: a complaint history review cannot be conducted as the lot/serial number was not reported.Conclusions: it was reported that femoral checkpoint was left in patient.Procedure was completed to remove the checkpoint.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text : device not returned.
Event or Problem Description
Patient was having a mako tha.Once cup was implanted the patient had a suspected pulmonary embolism.Surgeon closed wound to reposition patient so they could be assessed.Surgery was then called off.Femoral checkpoint was left in the patient.Surgeon was aware of this at the time and didn¿t want to reopen the wound to take it out.Update per response: "patient is doing well.Procedure was completed the following week and checkpoint was removed.".
Additional Manufacturer Narrative
Reported event: an event regarding user error involving a mako checkpoint was reported.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of the device history records cannot be conducted as the lot/serial number was not reported.-complaint history review: a complaint history review cannot be conducted as the lot/serial number was not reported.Conclusions: it was reported that femoral checkpoint was left in patient.Procedure was completed to remove the checkpoint.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
Patient was having a mako tha.Once cup was implanted the patient had a suspected pulmonary embolism.Surgeon closed wound to reposition patient so they could be assessed.Surgery was then called off.Femoral checkpoint was left in the patient.Surgeon was aware of this at the time and didn¿t want to reopen the wound to take it out.Update per response: "patient is doing well.Procedure was completed the following week and checkpoint was removed.".

• Brand Name: TIBIAL, CHECKPOINT, STERILE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17332872
• Report Number: 3005985723-2023-00115
• Device Sequence Number: 6608079
• Product Code: OLO
• UDI-Device Identifier: 00848486001353
• UDI-Public: 00848486001353
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 111651
• Device Catalogue Number: 111651
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 07/16/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male