• 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 THE MILL DISPOSABLE- MEDIUM 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 THE MILL DISPOSABLE- MEDIUM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 5400701000
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055. 2 devices were expected to be available for evaluation but were not received. This device is not repairable and was not returned to the user facility. There were no remedial actions taken. This device is labeled for single-use.
 
Event Description
This report summarizes 6 malfunction events in which the device had a white substance or dust in the packaging. 6 events occurred during a procedure; no patient impact.
 
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). 6 events were reported for this quarter. 4 devices were received for evaluation; 4 events were confirmed during testing. 4 devices were found to be affected by dust in the sterile packaging. 2 devices are available for evaluation but have not yet been received. This device is not repairable and was not returned to the user facility. There were no remedial actions taken. This device is labeled for single-use.
 
Event Description
This report summarizes 6 malfunction events in which the device had a white substance or dust in the packaging. 6 events occurred during a procedure; no patient impact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTHE MILL DISPOSABLE- MEDIUM
Type of DeviceINSTRUMENT, 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-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7219619
MDR Text Key176140289
Report Number0001811755-2018-00196
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported6
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5400701000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-