MAUDE Adverse Event Report: MAKO SURGICAL CORP. MICS, 6MM BALL BUR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	110135
Medical Device Problem Codes	Use of Device Problem (1670); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2018
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
During femur surface burring.Burr caught tip of surgeons glove while she pressed trigger.No harm to surgeon, just caught glove.Case type: pka.Picture is not from during surgery - it shows us trying to replicate what may have happened.It looked like her glove was loose and got caught up by the burr as power was engaged.
Additional Manufacturer Narrative
Reported event: mics, 6mm ball burr; during femur surface burring, burr caught tip of surgeons glove while she pressed trigger.Method & results: device evaluation and results: no device inspection could be completed as the product was not available for evaluation.Device history review: not performed as the mics, 6mm ball burr is an oem product.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 mics, 6mm ball burr; during femur surface burring, burr caught tip of surgeons glove while she pressed trigger failure of p/n: 110135, lot #: 17277027.There have been no other similar events for the referenced lot number.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.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.Device not returned.
Event or Problem Description
During femur surface burring.Burr caught tip of surgeons glove while she pressed trigger.No harm to surgeon, just caught glove.Case type: pka.Picture is not from during surgery - it shows us trying to replicate what may have happened.It looked like her glove was loose and got caught up by the burr as power was engaged.

• Brand Name: MICS, 6MM BALL BUR
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7908098
• Report Number: 3005985723-2018-00549
• Device Sequence Number: 1438106
• Product Code: OLO
• UDI-Device Identifier: 00848486016876
• UDI-Public: 00848486016876
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K172301
• 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): 11/01/2018

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: 110135
• Device Lot Number: 17277027
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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