MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Model Number 210080

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

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

Spd noticed a chip in the boot.Case type: no associated procedure.

Event Description

Spd noticed a chip in the boot.Case type: no associated procedure.

Manufacturer Narrative

Reported event: spd noticed a chip in the boot.Case type: no associated procedure.Product evaluation and results: visual inspection: confirms carbon fiber splitting on the boot assembly.Product history review: 1.Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 08-01-2017 with no reported discrepancies.2.Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 12-02-2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210080, lot 20174308202 shows 2 additional complaints related to the failure in this investigation pr # (b)(4), (b)(4).Conclusions: the event was confirmed.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.

• Brand Name: BOOT ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9528307
• MDR Text Key: 176610942
• Report Number: 3005985723-2019-00924
• 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: 01/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201743072802
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/28/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization