MAUDE Adverse Event Report: WIRE FX KIRSCHNER; PIN, FIXATION, SMOOTH

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2020

Event Type  No Answer Provided  

Event Description

Tip of k-wire broke off during drilling.

• Brand Name: WIRE FX KIRSCHNER
• Type of Device: PIN, FIXATION, SMOOTH
• MDR Report Key: 10471388
• MDR Text Key: 204922399
• Report Number: 10471388
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2020

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2020
• Date Report to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA