MAUDE Adverse Event Report: MAKO SURGICAL CORP. BURR GUARD ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Model Number	204992
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Separation Problem (4043); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
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
Sleeve inside long guard slipping out.It was noticed that the burr was coming loose during tibia bone prep.Case type: pka (mics).Surgical delay: 15 minutes.
Additional Manufacturer Narrative
Sleeve inside long guard slipping out.It was noticed that the burr was coming loose during tibia bone prep.Case type: pka (mics) surgical delay: = 15 minutes.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: review of the device history records indicate 22 devices were manufactured under lot 40m028790 and accepted into final stock on 03/13/2018.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 204992, lot # 40m028790 shows 01 additional complaint(s) related to the failure in this investigation, (b)(4).Conclusions: the event could not be confirmed.
Event or Problem Description
Sleeve inside long guard slipping out.It was noticed that the burr was coming loose during tibia bone prep.Case type: pka (mics).Surgical delay: = 15 minutes.

• Brand Name: BURR GUARD ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9320827
• Report Number: 3005985723-2019-00802
• Device Sequence Number: 343879
• Product Code: OLO
• UDI-Device Identifier: 00848486021856
• UDI-Public: 00848486021856
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K142530
• 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): 01/20/2020

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: 204992
• Device Catalogue Number: 204992
• Device Lot Number: 40M028790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 01/20/2020
• 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