Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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-KALAMAZOO RADIOLUCENT RIGHT ANGLE DRIVE; 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-KALAMAZOO RADIOLUCENT RIGHT ANGLE DRIVE; ARTHROSCOPE Back to Search Results
Catalog Number 4100355000
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, (b)(4).Two (2) events were reported for this quarter.Two (2) devices were received for evaluation.Two (2) device evaluations are in progress.There were no remedial actions taken.This device is not labeled for single-use.
 
Event Description
This report summarizes 2 malfunction events in which the device disassembled.Two (2) events had no known patient involvement or patient impact.
 
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055. supplemental rationale corrected data: 2 previously reported events are included in this follow-up record evaluation status: 2 reported events were confirmed during testing.2 devices were found to be affected by missing components.  additional information 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.
 
Event Description
This report summarizes 2 malfunction events in which the device disassembled.2 events had no known patient involvement or patient impact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RADIOLUCENT RIGHT ANGLE DRIVE
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7466901
MDR Text Key107196243
Report Number0001811755-2018-00753
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Number of Events Reported2
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number4100355000
Was Device Available for Evaluation? No
Date Manufacturer Received12/02/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-