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

Model Number 204992

Device Problems Activation, Positioning or Separation Problem (2906); Separation Problem (4043); Premature Separation (4045)

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

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the 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

Sleeve inside long guard slipping out.It was noticed that the burr was coming loose during tibia bone prep.Case type: pka (mics).Surgical delay: 15 minutes.

Manufacturer Narrative

Sleeve inside long guard slipping out.It was noticed that the burr was coming loose during tibia bone prep.Case type: pka (mics) surgical delay: = 15 minutes.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: review of the device history records indicate 22 devices were manufactured under lot 40m028790 and accepted into final stock on 03/13/2018.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 204992, lot # 40m028790 shows 01 additional complaint(s) related to the failure in this investigation, (b)(4).Conclusions: the event could not be confirmed.

Event Description

Sleeve inside long guard slipping out.It was noticed that the burr was coming loose during tibia bone prep.Case type: pka (mics).Surgical delay: = 15 minutes.

• Brand Name: BURR GUARD ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9320827
• MDR Text Key: 169293490
• Report Number: 3005985723-2019-00802
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486021856
• UDI-Public: 00848486021856
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

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: 204992
• Device Catalogue Number: 204992
• Device Lot Number: 40M028790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization