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 01/18/2022

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 multi-fire needle tip broke while passing suture.This occurred during a rotator cuff procedure.Another suture passer was used and a lasso was opened to pass sutures to complete the case successfully.The tip was not retrieved from the patient.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-13995n was received for investigation.Visual inspection identified that the distal tip of the scorpion needle, including the suture notch feature, had broken.No fragments were returned for analysis.The remainder of the needle strip was assessed using digital micrometer id: 224, and the thickness of the material met design specifications.Probable causes of the observed failure mode are attributed to consistently passing the needle through challenging tissue (thick or calcified) or through hitting bone.

• 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: 13470935
• MDR Text Key: 287678563
• Report Number: 1220246-2022-04388
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: 00888867015951
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

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: 13482415
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1