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

Model Number N/A

Device Problem Migration (4003)

Patient Problem Limb Fracture (4518)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

On january 13th 2023, microaire was notified via email with the uf/importer report # (b)(4) that a male who fractured his right wrist playing basketball in [redacted date].He underwent open reduction internal fixation on [redacted date], and revision surgery on [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 [redactive 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 this 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.

Manufacturer Narrative

As the product associated with the reported even was not returned, it was not possible to conduct an evaluation of the device.Since the part number and or lot # of the device was not provided, it was not possible to conduct a device history review.A review of the complaint history for microaire k-wires has revealed that this product line is performing as expected, with regard to the reported incident.With the information provided, it was not possible to identify a root cause; however potential user-related causes of the reported incident include off-axis drilling and improper selection of device.If additional information becomes available, this investigation will be re-opened.

• Brand Name: MICROAIRE KIRSCHNER WIRES
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville VA 22901
• Manufacturer Contact: erin knight ; 3590 grand forks boulevard; charlottesville, VA 22968 ; 4349758389
• MDR Report Key: 16296499
• MDR Text Key: 309268333
• Report Number: 2020601-2023-00003
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Male