MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209063

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 12/04/2018

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

Center rotary piece came out of the power.Photo attached.Surgical delay 5 minutes.

Manufacturer Narrative

Reported event: it was reported that center rotary piece came out of the power.Product evaluation and results: as per attached picture the failure mode was confirmed as the provided picture shows that the center rotary piece disassociated from the handpiece.Product history review: review of the product history records indicate 25 devices were manufactured under lot no k0aws and 22 devices were accepted into final stock on 03/01/2018.Review of qt18 - 03 - 0002 revealed that the non-conformance is not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, prodex lot k0aws shows 00 additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode was confirmed.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.

Event Description

Center rotary piece came out of the power.Surgical delay 5 minutes.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8200169
• MDR Text Key: 131594171
• Report Number: 3005985723-2018-00788
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209063
• Device Lot Number: 42010218/ 4203551
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization