• 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 CORDLESS DRIVER 4 HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

  • 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 CORDLESS DRIVER 4 HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 4405000000
Device Problems Sticking (1597); Positioning Problem (3009)
Patient Problem No Patient Involvement (2645)
Event Date 06/02/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Thirty-one events were reported for this quarter.Thirty-one devices were received for evaluation; thirty-one events were confirmed during testing.One device was found to be affected by non-stryker repairs.Eighteen devices were found to be affected by corrosion.Twelve devices were found to be affected by wear in the trigger assembly.There were no remedial actions taken.This device is not labeled for single-use.
 
Event Description
This report summarizes 31 malfunction events in which the device had a sticky trigger.Thirty events had no patient involvement; no patient impact.One reported event had no known patient involvement or patient impact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CORDLESS DRIVER 4 HANDPIECE
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6980876
MDR Text Key91242481
Report Number0001811755-2017-02136
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported31
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number4405000000
Was Device Available for Evaluation? No
Date Manufacturer Received06/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-