MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY- RIO BASE; STEREOTAXIC DEVICE, ROBOTICS

Model Number 112227

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/05/2019

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

Broken base array tilted.Case type: tka.Surgical delay: 30 minutes.Update: were any debris/components left inside of the patient? (yes/no) no.Were any components of the device missing or disassembled when the issue occurred? (yes/no) no.

Manufacturer Narrative

Reported event: broken base array tilted.Case type: tka,surgical delay: 30 minutes.Product evaluation and results: visual inspection shows the locking pin is broken on the base array.See attached image.Product history review: review of the device history records indicate 133 devices were manufactured under lot 19440418 and 0 devices were accepted into final stock on 12/06/2018.Review of qt 18 - 12 - 0023 revealed that all units were dispositoned as "accept per specification" and accepted into final stock on 12/11/2018.Non conformance were not related to the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112227, lot number 19440418 shows 2 additional complaints related to the failure in this investigation.Pr id : (b)(4).Conclusions: the failure is confirmed as alleged via visual 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.

Event Description

Broken base array tilted.Case type: tka.Surgical delay: 30 minutes.Update: were any debris/components left inside of the patient? (yes/no) no.Were any components of the device missing or disassembled when the issue occurred? (yes/no) no.

• Brand Name: ARRAY- RIO BASE
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9396775
• MDR Text Key: 177395475
• Report Number: 3005985723-2019-00878
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486017446
• UDI-Public: 00848486017446
• 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: 02/11/2020

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 Model Number: 112227
• Device Catalogue Number: 112227
• Device Lot Number: 19440418
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization