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

Catalog Number AR-13995N

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Insert (1316); Difficult to Remove (1528); Component Missing (2306)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

Patient demographics (date of birth, age at time of event, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.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 nitnol point demonstrated minimal scrape marks, indicating the device was not fired excessively.The mating part (instrument) was returned ((b)(4)/ ar-13999mf / batch 75259).Confirmed the needle strip thickness and width dimensions to be within specification.The typical cause for this type of event would be the use of excessive force to pass the needle through thick or hard tissue or hitting bone with the needle.There is a label on the device warning the user against re-sterilizing, reusing, hitting bone or use of excessive force as these may result in needle breakage or patient injury.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that during a rotator cuff repair procedure, as the surgeon was wrapping up suture passing, the last suture was not passing through the tissue.The surgeon removed and reloaded the needle.Upon passing, as he saw the needle come through the tissue, the tip was noticed to be missing.The tip of the needle broke off into the patient's shoulder and was not able to be retrieved.The needle was able to complete aprox.10 passes before breaking.The surgeon went back under the joint to try and retrieve the tip but couldn't.A fluoro was taken post-op and confirmed the tip in the soft tissue.The needle was being used with an ar-13999mf, lot: 75259 ((b)(4)).Not deployed or dry-fired.Needle did not hit bone or the cannula.Surgeon had a secure grip on the tissue but when the needle passed, he twisted his hand a little and the needle may have hit the top jaw of the scorpion.

• Brand Name: MULTIFIRE SCORPION 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337017
• MDR Report Key: 7341118
• MDR Text Key: 102467984
• Report Number: 1220246-2018-00094
• 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: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: AR-13995N
• Device Lot Number: 10176347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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
• Treatment: AR-13999MF, FASTPASS SCORPION, LOT 75259
• Patient Outcome(s): Other