MAUDE Adverse Event Report: ARTHREX, INC. SCORPION-MULTIFIRE NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number SCORPION-MULTIFIRE NEEDLE

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/10/2022

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 (b)(6) 2022 it was reported by a sales representative via sems that an ar-13995n scorpion needle tip broke off during a case.This was a rotator cuff repair on a 54 year old male.The surgeon used a side loader scorpion to pass all of the suture.The tear was large so the same scorpion needle was used multiple times, and the tissue was very thick.During one of the passes the tip broke off.It was not visible throughout the remainder of the procedure.The repair was finished successfully, and scans were taken after the case.The tip of the needle was sitting at the articular margin, under the repair, but the surgeon was not concerned and decided to not remove.The tip remains in the patient.

• Brand Name: SCORPION-MULTIFIRE NEEDLE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13620577
• MDR Text Key: 289184391
• Report Number: 1220246-2022-04518
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: 00888867015951
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/28/2022

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: SCORPION-MULTIFIRE NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 12438113
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 02/28/2022
• Date Device Manufactured: 01/04/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1