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

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP WIRE COLLET ARTHROSCOPE

  • 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 INSTRUMENTS-A DIVISION OF STRYKER CORP WIRE COLLET ARTHROSCOPE Back to Search Results
Model Number 4100062000
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2021
Event Type  malfunction  
Event Description
The user facility reported that the device overheated during testing prior to a procedure. There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameWIRE COLLET
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key12562488
MDR Text Key274276198
Report Number3015967359-2021-02087
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4100062000
Device Catalogue Number4100062000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-