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

Model Number SCORPION-MULTIFIRE NEEDLE

Device Problems Difficult to Remove (1528); Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2021

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

The procedure the patient underwent was an arthroscopic acromial decompression and mini open supraspinatus repair.The surgeon implanted 2 x 4.75 (ar_2324pslc) swivelocks, 1 loaded with fibertape and 1 with tigertape, these anchors formed the medial row for the tendon repair.The surgeon passed 2 tape limbs and 2 suture limbs, when he went to pass another suture with the scorpion, he noticed the tip of the needle was missing.The wound was then washed out with irrigation fluid.The needle tip which measured approximately 3mm (the multifire scorpion needle was measured against a new needle) was not retrieved during the wound wash out.The surgeon completed the rotator cuff supraspinatus repair passing the remaining tapes and sutures with a new scorpion multifire needle.Prior to finishing the surgery the surgeon checked the joint space for the needle tip which could not be seen.

• 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: 12335601
• MDR Text Key: 268437251
• Report Number: 1220246-2021-03527
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: 00888867015951
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/18/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/18/2021
• 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