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

Model Number SCORPION NEEDLE, KNEE

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported via a medwatch report that on (b)(6) 2021, while performing the arthroscopic shoulder surgery, it was noticed by scrub tech that a 2mm-3mm metal tip of the scorpion needle, ar-12990n, was missing.An intraoperative fluoroscopy was performed on the left shoulder and the metal was left in place per surgeon due to more potential complications in taking down the repair rotator cuff.No further information provided.

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.

• Brand Name: SCORPION NEEDLE, KNEE
• 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: 13087765
• MDR Text Key: 285059239
• Report Number: 1220246-2021-04188
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867199354
• UDI-Public: 00888867199354
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/27/2021

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 NEEDLE, KNEE
• Device Catalogue Number: AR-12990N
• Device Lot Number: 12962959
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/27/2021
• Date Device Manufactured: 03/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1