MAUDE Adverse Event Report: MAKO SURGICAL CORP. CABLE, J6 HIP, STAGE 2. INNER A; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 203578

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2020

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

Case description: (b)(4) - mps reported arm shaking during tibia and posterior femur cut.Case type : tha.Update: surgical delay "less than 15 minute delay.".

Manufacturer Narrative

Reported event: it was reported that case: case description: mps reported arm shaking during tibia and posterior femur cut.Case type : tha.Update: surgical delay "less than 15 minute delay." product evaluation and results: the field service engineer reported: problem reproduced (if applicable): yes.Work performed: i ran transmission and friction test.I tensioned both the j5 & the j6 transmission cables.I propagated both.Jp again ran his setup and the problem was not seen again.Product history review: cannot be performed as the lot/ serial is not reported.Complaint history review: cannot be performed as the lot/ serial is not reported.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.

Event Description

Case description: rob690 - mps reported arm shaking during tibia and posterior femur cut.Case type : tha.Update: surgical delay "less than 15 minute delay.".

• Brand Name: CABLE, J6 HIP, STAGE 2. INNER A
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10474300
• MDR Text Key: 205100200
• Report Number: 3005985723-2020-00288
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 203578
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other