MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH HD LONG ATTACHMENT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 110920

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

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

Event Date 01/08/2018

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

There is friction between the burr and the long attachment and a big noise, so the long attachment became very hot.Smoke was reported; no flames.Pka procedure.

Event Description

There is friction between the burr and the long attachment and a big noise, so the long attachment became very hot.Smoke was reported; no flames.Pka procedure.

Manufacturer Narrative

Reported event: there is friction between the burr and the long attachment and a big noise, so the long attachment became very hot.Smoke was reported; no flames.Pka procedure.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: not performed as the device is an oem product.Complaint history review: a review of complaints in trackwise related to p/n 110920 s/n (b)(4), shows no additional complaints related to the failure in this investigation.Conclusions: could not be confirmed as the product was not available for evaluation.The anspach hd long attachment has a shorter life expectancy than the anspach motor and is expected to be replaced once worn.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: ANSPACH HD LONG ATTACHMENT
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7242016
• MDR Text Key: 99046498
• Report Number: 3005985723-2018-00056
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

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 Catalogue Number: 110920
• Device Lot Number: K49312044621
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 03/18/2018
• Supplement Dates FDA Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization