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

Model Number	112227
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
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
Residue at post of base array.Case type / application: tka.
Event or Problem Description
Residue at post of base array.Case type / application: tka.
Additional Manufacturer Narrative
Reported event: residue at post of base array; case type / application: tka.Product inspection: visual inspection confirms residue at post of base array.Product history review: review of the device history records indicate (b)(4) devices were manufactured under p/n 112227 lot 19020416 and all were accepted into final stock on 29 sep 2016 with no reported discrepancies.Complaint history review: conclusion: the event was confirmed during visual inspection.Preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.No additional investigation or specific actions are h3 other text : device not returned.

• 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: 10697498
• Report Number: 0002249697-2020-02170
• Device Sequence Number: 3933922
• Product Code: OLO
• UDI-Device Identifier: 00848486017446
• UDI-Public: 00848486017446
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/01/2020

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: 112227
• Device Catalogue Number: 112227
• Device Lot Number: 19020416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/01/2020
• 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: Other