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

Catalog Number 209063

Device Problems Device Displays Incorrect Message (2591); Non Reproducible Results (4029)

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

Event Date 07/03/2018

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

Both mics in this email failed to make cuts during a tka procedure.They individually passed registration and set up, but a connection error popped up and wouldn¿t guide the surgeon into the cuts.It was until the third sterile mics that the feature finally worked.There was no patient harm or intervention.This caused a 10 minute delay.

Manufacturer Narrative

Reported event: it was reported that the mics failed to make cuts during a tka procedure as a connection error popped up and wouldn¿t guide the surgeon into the cuts and this caused a 10 minute delay.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: device history records indicate (b)(4) devices were manufactured under lot k0ajy and (b)(4) including s/n (b)(4) was accepted into final stock on 12/6/2018.A review of qt17-12-0015 revealed that the issue 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 k0ajy shows 4 additional complaint related to the failure in this investigation.The related complaints are (b)(4).Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is (b)(4) and capa (b)(4).Device not returned.

Event Description

Both mics in this email failed to make cuts during a tka procedure.They individually passed registration and set up, but a connection error popped up and wouldn¿t guide the surgeon into the cuts.It was until the third sterile mics that the feature finally worked.There was no patient harm or intervention.This caused a 10 minute delay.

• 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: 7685495
• MDR Text Key: 113910983
• Report Number: 3005985723-2018-00416
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• 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: LOT 42051117SN 4203203
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization