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

Catalog Number	210070
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	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of the 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
Scrub tech noticed splintering of carbon fiber, on base and extension, while installing them.Case type: tka.Update: "yes.Patient was under anesthesia.".
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections based on the results of investigation.Reported event: it was reported that scrub tech noticed splintering of carbon fiber, on base and extension, while installing them.Case type: tka.Update: "yes.Patient was under anesthesia." product evaluation and results: inspection showed small pits in the carbon fiber.Per inspection procedure qip 0005 appendix iv¿ table 4, small pits in the carbon fiber are acceptable.No product problem identified.Product history review: review of the device history records indicate 8 devices were manufactured and accepted into final stock on 09-19-2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210070, lot number 603889 shows no additional complaints related to the failure in this investigation.Conclusions: per d03391, the failure could not be determined as the product was not available for inspection.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 there have been no nc and capa associated with the product and failure mode reported in this event.H3 other text : product was not available for evaluation.
Event or Problem Description
Scrub tech noticed splintering of carbon fiber, on base and extension, while installing them.Case type: tka update: "yes.Patient was under anesthesia.".

• Brand Name: BAR EXTENSION
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8617553
• Report Number: 3005985723-2019-00363
• Device Sequence Number: 3020576
• Product Code: OLO
• UDI-Device Identifier: 00848486031862
• UDI-Public: 00848486031862
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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): 08/30/2019

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: 210070
• Device Lot Number: 603889
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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