MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY- RIO BASE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	112227
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
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
Base array was hit, caused anterior cut to be deep.Notched femur, had to stem femur.Case type: tka.Surgical delay = 16-30 minutes.
Additional Manufacturer Narrative
Reported event: base array was hit, caused anterior cut to be deep.Notched femur, had to stem femur.Case type: tka.Surgical delay = 16-30 minutes.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the device history records indicate 42 devices were manufactured and accepted into final stock on (b)(6) 2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n (b)(4), lot number 19440615, shows 3 additional complaints related to the failure in this investigation.Conclusions: 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 reopened.H3 other text : device not returned.
Event or Problem Description
Base array was hit, caused anterior cut to be deep.Notched femur, had to stem femur.Case type: tka; surgical delay = 16-30 minutes.

• Brand Name: ARRAY- RIO BASE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10457072
• Report Number: 3005985723-2020-00284
• Device Sequence Number: 3524218
• Product Code: OLO
• UDI-Device Identifier: 00848486017446
• UDI-Public: 00848486017446
• Combination Product (Y/N): N
• 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): 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 112227
• Device Catalogue Number: 112227
• Device Lot Number: 19440615
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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: Required Intervention