MAUDE Adverse Event Report: ARTHREX, INC. SUREFIRE SCORPION NEEDLE; MANUAL INSTR, GENERAL SURGICAL

Model Number SUREFIRE SCORPION NEEDLE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 3/22/2024, it was reported by a sales representative via sems-06522389 that an ar-13991n surefire scorpion needle tip broke off during use with no pieces breaking inside the patient.The case was completed with no further information provided.This was discovered during a rotator cuff repair procedure on (b)(6) 2024, with no reported patient harm.Additional information received on 4/9/2024: an fda medwatch notification was received via email.A facility administrator/supervisor reported that an ar-13991n surefire scorpion needle was used during an arthroscopy of the left shoulder with decompression and rcr procedure on (b)(6) 2024.The needle tip broke off while in use in the patient.The broken fragment could not be located so an x-ray was performed to ensure no foreign body was retained.

• Brand Name: SUREFIRE SCORPION NEEDLE
• Type of Device: MANUAL INSTR, GENERAL SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19127147
• MDR Text Key: 340407951
• Report Number: 1220246-2024-02096
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015920
• UDI-Public: 00888867015920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/17/2024

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
• Device Operator: Health Professional
• Device Model Number: SUREFIRE SCORPION NEEDLE
• Device Catalogue Number: AR-13991N
• Device Lot Number: 15076401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2023
• 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