MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY; OPERATING ROOM ACCESSORIES TABLE TRAY

Model Number	210080
Medical Device Problem Codes	Crack (1135); Material Frayed (1262)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2020
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
Boot is cracked and splintering.Case type: no associated procedure.
Event or Problem Description
Boot is cracked and splintering.Case type: no associated procedure.
Additional Manufacturer Narrative
Update to b2 and d2.Reported event: boot is cracked and splintering.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: 1.Review of the device history records indicate 50 devices were manufactured and accepted into final stock on 07-28-2017 with no reported discrepancies.2.Review of the device history records indicate 47 devices were manufactured and accepted into final stock on 07-29-2017 with no reported discrepancies.3.Review of the device history records indicate 2 devices were manufactured and accepted into final stock on 09-30-2017 with no reported discrepancies.4.Review of the device history records indicate 1 device was manufactured and accepted into final stock on 10-30-2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210080, lot 201743072802 shows 4 additional complaints related to the failure in this investigation.Conclusions: per 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.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.Device not returned.

• Brand Name: BOOT ASSEMBLY
• Common Device Name: OPERATING ROOM ACCESSORIES TABLE TRAY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9883854
• Report Number: 3005985723-2020-00182
• Device Sequence Number: 19557505
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 05/21/2020

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: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201743072802
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/21/2020
• 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; Other