MAUDE Adverse Event Report: MAKO SURGICAL CORP. BAR EXTENSION; STEREOTAXIC DEVICE, ROBOTICS

Model Number 210070

Device Problem Fracture (1260)

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

Event Date 12/05/2019

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

Cpd found putting and cracking along the extension bar to the back leg holder.There is concern that splintering could continue and cause harm to patient or staff while in use.The hospital would like the piece replaced.Case type: tka.

Manufacturer Narrative

Reported event: it was reported that "cpd found putting and cracking along the extension bar to the back leg holder.There is concern that splintering could continue and cause harm to patient or staff while in use.The hospital would like the piece replaced." the event was confirmed.Method & results: -device evaluation and results: visual inspection: the bar extension showed signs of wear.See attached image.-product history review: review of the device history records indicates (b)(4) device(s) were manufactured and accepted into final stock on 8-15-2018 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210070, lot 609557 shows 00 additional complaint(s) related to the failure in this investigation.Conclusion: the device was discovered during sterile processing and showed signs of wear.There was no surgical procedure associated with the reported event.Per d03391, preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved, and no actual or potential patient harm existed for the alleged event.This event meets the definition of preventive maintenance; no further investigation is required at this time.

Event Description

Cpd found putting and cracking along the extension bar to the back leg holder.There is concern that splintering could continue and cause harm to patient or staff while in use.The hospital would like the piece replaced.Case type: tka.

• Brand Name: BAR EXTENSION
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9513177
• MDR Text Key: 175877670
• Report Number: 3005985723-2019-00920
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486031862
• UDI-Public: 00848486031862
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 210070
• Device Catalogue Number: 210070
• Device Lot Number: 609557
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization