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	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
Reported event: it was reported that: "scrub tech noticed splintering of carbon fiber, on base and extension, while installing them.Update: "yes.Patient was under anesthesia."." the event was not confirmed.Method & results: device evaluation and results: not performed as the device(s) were not available for evaluation.Product history review: not performed as the lot number was reported as unknown.Complaint history review: not performed as the lot number was reported as unknown.Conclusion: the exact cause of the event could not be determined because the device was not available for evaluation.Capa 2127499 was issued 27-jun-2019 for issues with returned material from to the field.No further investigation for this event is possible at this time as no devices and / or insufficient information was available to the investigator.If devices and / or additional information become available, this investigation will be reopened.Corrective action/preventive action: capa 2127499 was issued 27-jun-2019 for issues with returned material from the field.
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: 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: 8617558
• Report Number: 3005985723-2019-00364
• Device Sequence Number: 2293334
• Product Code: OLO
• UDI-Device Identifier: 00848486031855
• UDI-Public: 00848486031855
• 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): 08/07/2019

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: 210060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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