• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. K-WIRE; PIN, FIXATION, SMOOTH

  • 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
 

ARTHREX, INC. K-WIRE; PIN, FIXATION, SMOOTH Back to Search Results
Lot Number 10210578
Device Problems Break (1069); Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/18/2020
Event Type  Injury  
Event Description
While using a kirschner wire (k-wire), there was a piece noted to be missing.Surgeon retrieved the broken piece.An intraop x-ray was completed, and confirmed the k-wire fragment was removed.Surgeon aware, procedure continued and completed.Near miss.No patient harm.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
K-WIRE
Type of Device
PIN, FIXATION, SMOOTH
Manufacturer (Section D)
ARTHREX, INC.
MDR Report Key10436646
MDR Text Key204174209
Report NumberMW5096177
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 08/19/2020
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
Device Operator Health Professional
Device Lot Number10210578
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/20/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age38 YR
-
-