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 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-KALAMAZOO WIRE COLLET; ARTHROSCOPE Back to Search Results
Catalog Number 4100062000
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/28/2015
Event Type  malfunction  
Manufacturer Narrative
The device was scrapped by the manufacturer.
 
Event Description
It was reported that during a surgical procedure at the user facility, the device was spitting metal shavings.When the metal shavings were noticed by the customer, the debris was washed it off the skin and irrigated the surgical site.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WIRE COLLET
Type of Device
ARTHROSCOPE
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 Key5017533
MDR Text Key23530785
Report Number0001811755-2015-03029
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Report Date 07/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4100062000
Device Lot Number10043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2015
Date Manufacturer Received07/28/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-