MAUDE Adverse Event Report: MAKO SURGICAL CORP. BASE BAR ASSM; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	210060
Medical Device Problem Codes	Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
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
The base bar (part number 210060) arrived and when removed from packaging had exposed carbon fibers.This was a new product to replace the base bar for (b)(4).
Additional Manufacturer Narrative
Reported issue: it was reported that the base bar had chips in the carbon fiber.Product history review: review of the device history records indicate 100 devices were manufactured and (b)(4) "devices" were accepted into final stock on 11/11/2017.A review of qt17-11-0041 revealed that the non-conformance is not related to the failure alleged in this compliant.Complaint history review: a review of complaints related to p/n 210060, lot 603999 shows no additional complaint(s) related to the failure in this investigation.Inspection: inspection showed no damage to the part.Part was sent back through receiving inspection and re-inspected.Part passed inspection.Conclusion: the failure mode could not be confirmed.Per (b)(4), preventive maintenance identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.No additional investigation or specific actions are required.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there has been no nc or capa associated with the product and failure mode reported in this event.".
Event or Problem Description
The base bar (part number 210060) arrived and when removed from packaging had exposed carbon fibers.This was a new product to replace the base bar for (b)(4).

• Brand Name: BASE BAR ASSM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8427806
• Report Number: 3005985723-2019-00238
• Device Sequence Number: 19167767
• Product Code: OLO
• UDI-Device Identifier: 00848486031855
• UDI-Public: 00848486031855
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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: Other
• Device Catalogue Number: 210060
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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