MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNIVERSAL DRIVER-ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112340
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
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
While impacting the tibial checkpoint on the femur for a mako tha, a piece broke off from the tip that grabs the checkpoint.Case type: tha.
Event or Problem Description
While impacting the tibial checkpoint on the femur for a mako tha, a piece broke off from the tip that grabs the checkpoint.Case type: tha.
Additional Manufacturer Narrative
Reported event: -customer reported that while impacting the tibial checkpoint on the femur for a mako tha, a piece broke off from the tip that grabs the checkpoint.Device evaluation and results: -device evaluation was not performed and the universal driver, assembly event was not confirmed.Device history review: -review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 05-23-16 with no reported discrepancies.Complaint history review: -based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding the universal driver assembly.There has been 3 other events for the referenced lot number.Prs # (b)(4) - were found to be from the same lot as the part in this complaint.The parts from these prs displayed a similar failure.Conclusions: -no product inspection could be completed due to the product not being returned.Corrective action/preventive action: -as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.

• Brand Name: UNIVERSAL DRIVER-ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8547683
• Report Number: 3005985723-2019-00316
• Device Sequence Number: 400072
• Product Code: OLO
• UDI-Device Identifier: 00848486017460
• UDI-Public: 00848486017460
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121064
• 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): 06/27/2019

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: 112340
• Device Lot Number: 06131015
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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: Hospitalization