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

Model Number 210080

Device Problems Crack (1135); Material Frayed (1262)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2020

Event Type  malfunction  

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 Description

Boot is cracked and splintering.Case type: no associated procedure.

Event Description

Boot is cracked and splintering.Case type: no associated procedure.

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
• Type of Device: OPERATING ROOM ACCESSORIES TABLE TRAY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9883854
• MDR Text Key: 185114393
• Report Number: 3005985723-2020-00182
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201743072802
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other