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

Catalog Number	111651
Medical Device Problem Codes	Break (1069); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
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
When removing tibial checkpoint from tibial tuberosity, the checkpoint snapped off leaving part of the checkpoint in the patient.Tka.
Event or Problem Description
When removing tibial checkpoint from tibial tuberosity, the checkpoint snapped off leaving part of the checkpoint in the patient.Tka.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported event: when removing tibial checkpoint from tibial tuberosity, the checkpoint snapped off leaving part of the checkpoint in the patient.Tka.Device evaluation and results: the product was unavailable for inspection as the product was not returned.Device history review: review of the product history records indicate (b)(4) devices were manufactured under lot no w55806 and accepted on 12/14/2017.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111651, l/n w55806 shows 0 additional complaints under investigation 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.Device not returned.

• 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: 7920125
• Report Number: 3005985723-2018-00560
• Device Sequence Number: 16720656
• Product Code: OLO
• UDI-Device Identifier: 00848486001353
• UDI-Public: 00848486001353
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 111651
• Device Lot Number: W55806
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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