MAUDE Adverse Event Report: BRASSELER USA BRASSELER USA K-WIRES - SMOOTH/PLAIN; DOUBLE TROCAR K-WIRE

Model Number KM172-26-45S

Device Problems Break (1069); Entrapment of Device (1212); Material Twisted/Bent (2981)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

The brasseler employee who previously submitted emdrs for our company is no longer with the company.Due to the time needed in setting up a new emdr account and a backup- the mdr due date was missed.Contacted fda for guidance and was advised to note this reason.

Event Description

As reported by the health care professional, "the k-wire bent into the bone and broke.The surgeon was unable to retrieve it without causing further damage to the bone.There were no adverse effects to the patient or the staff.".

• Brand Name: BRASSELER USA K-WIRES - SMOOTH/PLAIN
• Type of Device: DOUBLE TROCAR K-WIRE
• Manufacturer (Section D): BRASSELER USA; one brasseler blvd; savannah GA 31419
• Manufacturer (Section G): NEEDLTECH; 452 john l. dietsch blvd; north attleboro MA 31419
• Manufacturer Contact: rachel zellers ; one brasseler blvd; savannah, GA 31419 ; 8008414522
• MDR Report Key: 9349099
• MDR Text Key: 207327301
• Report Number: 2025102-2019-00004
• 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): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/15/2019

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
• Device Operator: Health Professional
• Device Model Number: KM172-26-45S
• Device Catalogue Number: 5007973M0
• Device Lot Number: NR4HU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1