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 Device Embedded In Tissue or Plaque (3165)

Event Date 02/13/2020

Event Type  Injury  

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.

Event Description

It was reported by the sales rep, that during a rotator cuff repair procedure, upon insertion the tip of the ar-13995n, needle broke off.The broken piece remains in the patient.

Manufacturer Narrative

The failure mode could not be determined, but the broken needle point condition can be caused by consistently passing the needle through challenging tissue (thick or calcified) or hitting bone.The buckled needle strip condition is typically caused by the device skiving under thick tissue or distorting distally under the jaw.The distal end of the nitinol point demonstrated minimal scrape marks, indicating the device was not fired excessively.The mating (instrument) was not returned or identified.Confirmed the needle strip thickness and width dimensions to be within specification.

• 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
• MDR Report Key: 9756826
• MDR Text Key: 190534523
• Report Number: 1220246-2020-01739
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: 00888867015951
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: SCORPION-MULTIFIRE NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 10328358
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 03/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other