MAUDE Adverse Event Report: MAKO SURGICAL CORP. PROBE- BLUNT STRAIGHT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	110800
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
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
The tip of the green probe became detached from the arrays.This caused a problem with the verification of the calibration.Case type: tka.
Event or Problem Description
The tip of the green probe became detached from the arrays.This caused a problem with the verification of the calibration.Case type: tka.
Additional Manufacturer Narrative
Reported issue: the tip of the green probe became detached from the arrays.This caused a problem with the verification of the calibration.Case type: tka.Product history review: review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 09/20/2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints related to p/n 110800, lot 19200616 shows no additional complaint(s) related to the failure in this investigation.Visual inspection: visual inspection shows that the probe tip is not fully seated against the probe body.Dimensional inspection: dimensional inspection was not completed as the item has been used and the dimensions and tolerances on the print are no longer an accurate representation of the part.Material analysis: material analysis was not completed as no material failure was alleged.Conclusion: it was confirmed that the probe tip is not fully seated against the probe body and the probe failed to report probe check values under 1.0 mm using different end effector arrays.The hazard/harm combination from this complaint has been previously identified.No additional investigation or specific actions are required.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no ncs or capas associated with the product and failure mode reported in this event.

• Brand Name: PROBE- BLUNT STRAIGHT
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7747770
• Report Number: 3005985723-2018-00456
• Device Sequence Number: 16473757
• Product Code: OLO
• UDI-Device Identifier: 00848486002695
• UDI-Public: 00848486002695
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/02/2018

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 Catalogue Number: 110800
• Device Lot Number: 19200616
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 11/02/2018
• 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: Hospitalization