MAUDE Adverse Event Report: ARGON MEDICAL DEVICES HAWKINS III FLEXSTRAND BLN 20GA X 5CM; HAWKINS II FLEXSTRAND BLN

Model Number 253050

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

Sample is unavailable for evaluation.Image was provided for investigation.A follow-up report will be provided once the image has been reviewed.

Event Description

We received on june 1st late afternoon the following complaint from rabin (beilinson) medical center, as outlined below the hospital queries if this is a known issue, if happened before and if reported.Product details: argon breast localization needle batch 11401333 cat no 253050.Complaint: on 24 may 2022, a marking press needle was inserted.During a surgery that day, it broke.No information about patient provided.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and although a temporary deviation notice was given, there is no evidence that it contributes to the complaint.It was not necessary to check any other documentation in the course of investigating this complaint.1/2 broken needle returned and was used.Looked to be cut cleanly and slightly unraveled.Attached imaging showed the break off occurred during procedure.A review of the sample returned by the customer was performed.The customer returned the back half of the hook wire for a hawkins iii, severed cleanly slightly more than half way up the wire.According to imaging provided with the complaint, the hook wire half was still embedded in tissue when the wire severed.This is not a known issue; in fact, this is the first hawkins iii hook wire breakage ever recorded.The break did not happen at any known stress points on the wire (at the crimp site, on or near the ball weld for the hook), but instead apparently occurred quite near the surface of the skin during the operation.Given the clean nature of the severance (wire strands that make up the hook wire are of uniform length and only slightly unraveled), this most likely occurred as a result of an event in the user environment.The complaint is not confirmed for a manufacturing defect.

Event Description

We received on june 1st late afternoon the following complaint from (b)(6)medical center, as outlined below ¿ the hospital queries if this is a known issue, if happened before and if reported.Product details: argon breast localization needle batch 11401333 cat no 253050 complaint: on(b)(6)2022, a marking press needle was inserted.During a surgery that day, it broke (see image provided on next page).No information about patient provided.

• Brand Name: HAWKINS III FLEXSTRAND BLN 20GA X 5CM
• Type of Device: HAWKINS II FLEXSTRAND BLN
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 14644001
• MDR Text Key: 295492168
• Report Number: 0001625425-2022-01020
• Device Sequence Number: 1
• Product Code: GDM
• UDI-Device Identifier: 00886333003860
• UDI-Public: 00886333003860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K870523
• 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,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 253050
• Device Catalogue Number: 253050
• Device Lot Number: 11401333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other