MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIGH SPEED ROTARY ATTACHMENT; STEREOTAXIC DEVICE, ROBOTICS

Model Number	204990
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2019
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
During bone preparation in a mako pka 3.0 case the surgeon noted that the rotary burr attachment was heating up and getting hot during use.Upon further investigation it was noticed there was some sort of lubricant/oil being released from the body of the rotary attachment.This lubricant/oil was originating from the rotary attachment body.The issue was notices whilst the instrument was being used by the surgeon.
Event or Problem Description
During bone preparation in a mako pka 3.0 case the surgeon noted that the rotary burr attachment was heating up and getting hot during use.Upon further investigation it was noticed there was some sort of lubricant/oil being released from the body of the rotary attachment (see attached photo).This lubricant/oil was originating from the rotary attachment body.The issue was notices whilst the instrument was being used by the surgeon.
Additional Manufacturer Narrative
Reported event: during bone preparation in a mako pka 3.0 case the surgeon noted that the rotary burr attachment was heating up and getting hot during use.Upon further investigation it was noticed there was some sort of lubricant/oil being released from the body of the rotary attachment.This lubricant/oil was originating from the rotary attachment body.The issue was notices whilst the instrument was being used by the surgeon.Product inspection not performed as no items were returned.Product history review of the device history records indicates (b)(4) device(s) were manufacturer ed and accepted into final stock on (b)(6) 2017, (b)(6) 2018, and (b)(6) 2018; and (b)(4) device(s) were rejected.Review of qt17-06- 0024 indicates the following: (b)(4) device(s) with s/n (b)(6) were quarantined due to dimensional discrepancies; a quarantine disposition was not confirmed.Complaint history review a review of complaints in catsweb and trackwise related to p/n 204990, lot 40m947030 shows (b)(4) additional complaint(s) related to the failure in this investigation.These include the following pr(s): (b)(4).Conclusion the event was not confirmed as the product was not returned.Nc/capa review 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 : device not returned.

• Brand Name: HIGH SPEED ROTARY ATTACHMENT
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8946464
• Report Number: 3005985723-2019-00605
• Device Sequence Number: 13499908
• Product Code: OLO
• UDI-Device Identifier: 00848486021849
• UDI-Public: 00848486021849
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K142530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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 Model Number: 204990
• Device Catalogue Number: 204990
• Device Lot Number: LOT- 40M947030 SN-400014
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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
• Patient Age: 55 YR