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

Catalog Number 209063

Device Problems Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 05/13/2019

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

Switched to straight saw blade after distal and posterior champher cuts were made and could not pass saw checkpoint.Attempted to reregistered 2 times and got registration error of.5 and.6 respectively.Exited out of software and tried again with the same result.Changed out handpiece, registered and everything passed and easily able to get through registration and straight saw blade cuts.Case type: tka.Surgical delay: 16-30 minutes.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: switched to straight saw blade after distal and posterior champher cuts were made and could not pass saw checkpoint.Attempted to reregistered 2 times and got registration error of.5 and.6 respectively.Exited out of software and tried again with the same result.Changed out handpiece, registered and everything passed and easily able to get through registration and straight saw blade cuts.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Product history review: review of the product history records indicate 25 devices were manufactured under lot no k082e and accepted into final stock on 08/10/2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints related to p/n 209063, prodex lot k082e shows no additional complaint(s) related to the failure in this investigation.Conclusions: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.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.H3 other text : device not returned.

Event Description

Switched to straight saw blade after distal and posterior champher cuts were made and could not pass saw checkpoint.Attempted to reregistered 2 times and got registration error of.5 and.6 respectively.Exited out of software and tried again with the same result.Changed out handpiece, registered and everything passed and easily able to get through registration and straight saw blade cuts.Case type: tka.Surgical delay: 16-30 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: 8633073
• MDR Text Key: 145846507
• Report Number: 3005985723-2019-00374
• 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: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• 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: 42030716/4200926
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization