MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL, CHECKPOINT, STERILE; STEREOTAXIC DEVICE, ROBOTICS

Model Number	111651
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
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
Tibia checkpoint was left in patient.Checkpoint became dislodged during teaming and fell into boney defect in acetabulum and could not be recovered.Case type: tha.Surgical delay: 16-30 minutes.
Additional Manufacturer Narrative
Reported event: tibia checkpoint was left in patient.Checkpoint became dislodged during teaming and fell into bony defect in acetabulum and could not be recovered.Case type: tha.Surgical delay : 16-30 minutes.Product evaluation and results: as per the x-ray provided the checkpoint can be seen left in the patients body.Product history review: review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 09/23/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111651, l/n w64053-2 shows no additional complaints related to the failure in this investigation.Conclusions: the failure of checkpoint left in patient body can be confirmed from the x- ray provided in the communication log, there is no failure of the device.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 that there have been no nc¿s associated with the product and failure mode reported in this event.
Event or Problem Description
Tibia checkpoint was left in patient.Checkpoint became dislodged during teaming and fell into bony defect in acetabulum and could not be recovered.Case type: tha.Surgical delay : 16-30 minutes.

• Brand Name: TIBIAL, CHECKPOINT, STERILE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9654852
• Report Number: 3005985723-2020-00065
• Device Sequence Number: 16850207
• Product Code: OLO
• UDI-Device Identifier: 00848486001353
• UDI-Public: 00848486001353
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• 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): 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 111651
• Device Catalogue Number: 111651
• Device Lot Number: W64053-2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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: Hospitalization
• Patient Age: 62 YR