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

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).

• Brand Name: K-WIRE
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 10436646
• MDR Text Key: 204174209
• Report Number: MW5096177
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: 10210578
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR