MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY- RIO BASE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112227
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2018
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
The base array may be bent.I could not get the cutter check to pass during a tka procedure.We changed out the base array eventually and were able to pass.There was a thirty minute delay in surgery yes patient was under anesthesia don't have identifier.This was a tka procedure.
Event or Problem Description
The base array may be bent.I could not get the cutter check to pass during a tka procedure.We changed out the base array eventually and we¿re able to pass.There was a thirty minute delay in surgery?.Yes, patient was under anesthesia don¿t have identifier.This was a tka procedure.
Additional Manufacturer Narrative
It was reported that the arrays was bent.The product was unavailable for inspection as the product was not returned.Review of the product history records indicate 128 devices were manufactured under lot no 19060116 and accepted into final stock on 09/08/2016.No non-conformances were identified during inspection.A review of complaints in catsweb and trackwise related to p/n 112227, lot 19060116 shows no additional complaints related to the failure in this investigation.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 re-opened.No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: ARRAY- RIO BASE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7920124
• Report Number: 3005985723-2018-00557
• Device Sequence Number: 19345925
• Product Code: OLO
• UDI-Device Identifier: 00848486017446
• UDI-Public: 00848486017446
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/18/2019

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: 112227
• Device Lot Number: 19060116¿
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 04/18/2019
• 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