• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER CORP /MAKO SURGICAL CORP. MICS HANDPIECE & SAW ATTACHMENT MAKO HANDPIECE & SAW ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMICS HANDPIECE & SAW ATTACHMENT MAKO HANDPIECE & SAW ATTACHMENT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER CORP /MAKO SURGICAL CORP.
kalamazoo MI 49002
MDR Report Key13734924
MDR Text Key287248471
Report NumberMW5108041
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/09/2022
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received03/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number209063
Device Catalogue Number209063
Device Lot Number42090921
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2022
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

-
-