MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIGH SPEED ROTARY ATTACHMENT; STEREOTAXIC DEVICE, ROBOTICS

Model Number 204990

Device Problems Fluid/Blood Leak (1250); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 10/02/2019

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

Piece is leaking oil.Case type: pka (mics).Patient under anesthesia.

Event Description

Piece is leaking oil.Case type: pka (mics).Patient under anesthesia.

Manufacturer Narrative

Reported event: it was reported that piece is leaking oil case type: pka (mics) patient under anesthesia.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 50 devices were manufactured and 49 accepted (including serial 4001390) into final stock on 06/17/2019 with no reported discrepancies.Review of qt 19-06-0080 revealed that the non-conformance is unrelated to the failure alleged in the event.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 204990, lot 40m115490 shows 0 additional complaints related to the failure in this investigation.Conclusions: 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.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.H3 other text : device not returned.

• Brand Name: HIGH SPEED ROTARY ATTACHMENT
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9191239
• MDR Text Key: 167355334
• Report Number: 3005985723-2019-00734
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486021849
• UDI-Public: 00848486021849
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 204990
• Device Catalogue Number: 204990
• Device Lot Number: 4001390
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization