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 REAMER; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  • 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 REAMER; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 4100231000
Medical Device Problem Codes Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/18/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device had a piece broken off during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The user facility reported that the device had a piece broken off 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 Name
REAMER
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9335742
Report Number0001811755-2019-03794
Device Sequence Number1873641
Product Code ERL
UDI-Device Identifier04546540068224
UDI-Public04546540068224
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K943323
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number4100231000
Device Catalogue Number4100231000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Initial Date Received by Manufacturer 10/23/2019
Supplement Date Received by Manufacturer04/07/2020
Initial Report FDA Received Date11/18/2019
Supplement Report FDA Received Date04/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-