MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS, LLC MICROAIRE KIRSCHNER WIRES; PIN, FIXATION, SMOOTH

Lot Number 0

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 11/02/2022

Event Type  malfunction  

Event Description

[redacted name] is a male who fractured his right wrist playing basketball in [redacted date].He underwent open reduction internal fixation in [redacted date], and revision surgery in [redacted date].His initial surgery was not with hss however his revision surgery with placement of a bone screw and kwire hardware took place on [redacted date] at hss nyc with dr.[redacted name].On [redacted date] the patient presented to hss, where dr.[redacted name] performed removal of right wrist hardware.Prior to the procedure, he noted that the pin had migrated slightly necessitating operative removal under anesthesia.The pin was removed successfully, however there were retained fragments identified by fluoroscopy following pin removal.Two minute fragments were left in place by dr.[redacted name] after extensive search and removal attempt rather than sustaining the risk of wider open operative dissection.

• Brand Name: MICROAIRE KIRSCHNER WIRES
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks blvd; charlottesville VA 22911
• MDR Report Key: 16156711
• MDR Text Key: 307275964
• Report Number: 16156711
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6205 DA
• Patient Sex: Male