MAUDE Adverse Event Report: BRASSELER USA KM172-26-45S STERILE DOUBLE TROCAR K-WIRE

Catalog Number	KM172-26-45S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brasseler is reporting this event in an abundance of caution.The root cause cannot be confirmed due to the inability of brasseler to perform an investigation of the broken k-wire which was not returned by the customer.
Event or Problem Description
During an achilles tendon repair surgery, the doctor was inserting a 1.1mm k-wire into the patient's calcaneus bone as an anchor guide, but it broke in the middle, leaving 40mm of the wire lodged in the bone.He attempted to remove it with a tonsil clamp and needle holder, but it couldn't be extracted, so it was decided to leave it in place.No patient information was provided.

• Brand Name: KM172-26-45S STERILE DOUBLE TROCAR K-WIRE
• Common Device Name: K-WIRE
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• Manufacturer Contact: rod rylands ; 1 brasseler blvd; savannah, GA 31419 ; 4253087468
• MDR Report Key: 20343904
• Report Number: 2025102-2024-00009
• Device Sequence Number: 20814878
• Product Code: HTY
• UDI-Device Identifier: 00887919491057
• UDI-Public: 00887919491057
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/01/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: KM172-26-45S
• Device Lot Number: NZ4YC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown