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

Catalog Number 209063

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

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

Event Date 06/14/2018

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

It is reported that a mics handpiece broke during surgery.

Manufacturer Narrative

Reported event: it was reported that it is reported that a mics handpiece broke during surgery.Product evaluation and results: visual inspection: visual inspection revealed no physical damage of unit.Dimensional inspection: dimensional inspection was not completed.Reported problem was a functional issue.Material analysis: material analysis was not completed because the failure was functional.Functional inspection: the handpiece was tested in the handpiece test (qip0243) and failed.The motor did not spin during the test.Product history review: device history records indicate 25 devices were manufactured under lot k09gr and 25 including s/n (b)(4) were accepted into final stock on 5/1/17.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, prodex lot number k09gr shows no additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode was confirmed.The handpiece driver electronics (commutation board) communicates with the handpiece trigger.A failure of this communication will break the process that allows the trigger command to result in the motor spinning.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that nc 1414517 and capa 1450904 are associated with the failure mode reported in this event.

Event Description

It is reported that a mics handpiece broke during surgery.

• 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: 7611052
• MDR Text Key: 111858678
• Report Number: 3005985723-2018-00373
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

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: 209063
• Device Lot Number: TBD
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 09/28/2018
• Supplement Dates FDA Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization