MAUDE Adverse Event Report: STRYKER CORP /MAKO SURGICAL CORP. MICS HANDPIECE & SAW ATTACHMENT MAKO HANDPIECE & SAW ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209063

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

Mics handpiece with saw attachment began shuttering during surgical use.Identified components given to stryker representative (b)(4).Fda safety report id # (b)(4).

• Brand Name: MICS HANDPIECE & SAW ATTACHMENT MAKO HANDPIECE & SAW ATTACHMENT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER CORP /MAKO SURGICAL CORP.; kalamazoo MI 49002
• MDR Report Key: 13734924
• MDR Text Key: 287248471
• Report Number: MW5108041
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/09/2022
• 2 Devices were Involved in the Event: 1 2

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: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42090921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White