MAUDE Adverse Event Report: MAKO SURGICAL CORP. CPCI MOTION CONTROL ASSEMBLY 3.0 ROHS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 211123

Device Problems Computer Software Problem (1112); Loss of Power (1475)

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

Event Date 05/22/2019

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

Mps (b)(6) reported 3 mics handpieces not getting power once in haptics; asset: rob318, case number: (b)(4).Case type tka; update: "a little less than 30 mins surgical delay.Longer tourniquet time".

Event Description

Mps casie wilson reported 3 mics handpieces not getting power once in haptics asset: (b)(6).(b)(4).Case type tka.Update: "a little less than 30 mins surgical delay.Longer tourniquet time.".

Manufacturer Narrative

Update to b2 and d2.Reported event: it was reported that mps reported 3 mics handpieces not getting power once in haptics asset: (b)(6).Case type tka.Update: "a little less than 30 mins surgical delay.Longer tourniquet time.".Product evaluation and results: as per work order, successfully replaced cpci assembly.System investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Product history review: review of the device history records indicate (b)(6) was inspected and accepted into final stock after being handled via npr.Review of npr revealed that the non conformance is unrelated to the failure alleged in the investigation.Complaint history review: a review of complaints in catsweb and trackwise related to (b)(6) shows 1 additional complaint related to the failure in this investigation.Conclusions: the failure is confirmed via inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.

• Brand Name: CPCI MOTION CONTROL ASSEMBLY 3.0 ROHS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8664642
• MDR Text Key: 146948016
• Report Number: 3005985723-2019-00411
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211123
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other