MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW; STEREOTAXIC DEVICE, ROBOTICS

Model Number 212480

Device Problems Noise, Audible (3273); Premature Separation (4045)

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

Event Date 11/04/2019

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

Over the last two weeks three mics powers have needed replacement due to screws in the mouth, where the attachments insert, breaking or falling out.Attachments are very loud during cutting and vibrating violently.Attachments seem to be ruining mics.All attachments need replacement.Case type: tka.

Event Description

Over the last two weeks three mics powers have needed replacement due to screws in the mouth, where the attachments insert, breaking or falling out.Attachments are very loud during cutting and vibrating violently.Attachments seem to be ruining mics.All attachments need replacement.Case type: tka.

Manufacturer Narrative

Reported event: it was reported that over the last two weeks three mics powers have needed replacement due to screws in the mouth, where the attachments insert, breaking or falling out.Attachments are very loud during cutting and vibrating violently.Attachments seem to be ruining mics.All attachments need replacement.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 (b)(4) were accepted into final stock on 11-10-2017.A review of qt 17-11-0039 revealed that the non-conformance is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 212480, lot number 35011017 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.

• Brand Name: 2.7 DEGREE ANGLED SAGITAL SAW
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9390321
• MDR Text Key: 189676139
• Report Number: 3005985723-2019-00864
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032128
• UDI-Public: 00848486032128
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212480
• Device Catalogue Number: 212480
• Device Lot Number: 35011017 / 3502312
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization