MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO 2.7 DEGREE ANGLED SAGITTAL SAW ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 212480

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2022

Event Type  malfunction  

Event Description

Mako robot was used for left knee replacement. 2. 7 degree angled sagittal saw attachment would not lock onto mako arm. Device released to on-site company representative (b)(6). Company sending a replacement. Fda safety report id # (b)(4).

• Brand Name: MAKO 2.7 DEGREE ANGLED SAGITTAL SAW
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.
• MDR Report Key: 13976773
• MDR Text Key: 288496248
• Report Number: MW5108695
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 212480
• Device Catalogue Number: 212480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No