MAUDE Adverse Event Report: BRASSELER USA KM172-26-62S; K-WIRE

Catalog Number	5007975M0
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Brasseler received a medwatch form fda3500a from the fda that was submitted to the fda as a product problem by the customer.Brasseler has no prior record of this event.A small piece of the k-wire broke off inside the sacral 1 vertebral body as the surgeon was attempting to implant a screw, the surgeon stated that the k-wire piece is not retreatable and it will stay in the patient's vertebra.
Event or Problem Description
Brasseler received a medwatch form fda3500a (b)(4) from the fda that was submitted to the fda as a product problem by the customer.Brasseler has no prior record of this event.A small piece of the k-wire broke off inside the sacral 1 vertebral body as the surgeon was attempting to implant a screw, the surgeon stated that the k-wire piece is not retreatable and it will stay in the patient's vertebra.
Event or Problem Description
Brasseler received a medwatch form fda 3500a ((b)(4)) from the fda that was submitted to the fda as a product problem by the customer.Brasseler has no prior record of this event.A small piece of the k-wire broke off inside the sacral 1 vertebral body as the surgeon was attempting to implant a screw, the surgeon stated that the k-wire piece is not retreatable and it will stay in the patient's vertebra.
Additional Manufacturer Narrative
The customer returned product for this adverse event.After evaluation of the product that was returned by the customer it was determined that the product is not brasseler's item km172-26-62s k-wire.062 x 6 inches as reported and identified in the medwatch form fda3500a ((b)(4)).The product that was returned to brasseler for evaluation measured.062 x 19.5 inches.Brasseler does not manufacture a k-wire product with these dimensions and therefore we conclude that the returned k-wire that was involved in the reported incident was not a brasseler product.Brasseler will contact the customer to arrange to have product returned to customer.

• Brand Name: KM172-26-62S
• 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: 19355781
• Report Number: 2025102-2024-00003
• Device Sequence Number: 3797689
• Product Code: HTY
• UDI-Device Identifier: 00887919491088
• UDI-Public: 00887919491088
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024

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: 5007975M0
• Device Lot Number: NY1B7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 08/12/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White