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

Model Number	MULTIFIRE SCORPION NEEDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair surgery the scorpion needle broke during passage trough the supraspinatus.The needle knocked on the acromium several times.All fragments were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to do a second surgery.
Additional 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.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Update avoe 02-apr-2024.It was confirmed that no change of the procedure was required and the surgery was finished successfully with a new device with the same part number.The surgeon tried to remove the broken tip of the needle but was unsuccessful.
Additional Manufacturer Narrative
The complaint is confirmed based on the x-ray customer provided photo, which displays the distal end of the scorpion needle was broken.No photo was provided of the damaged device.However, without the return of the device for physical evaluation, the most likely cause for the reported failure can be attributed to user error of the device due to using excessive force to pass the needle through fibrous/calcific tissue, unsecured grasp of tissue, dry repetitive actioning outside of the surgical site, and/or prying/leveraging the device during use.Dfu-0392-sub-eo warns against the usages listed to help avoid needle breakage and potential patient injury.
Event or Problem Description
Update avoe 29-apr-2024.It was further reported that the tip broke and became lodged in the tendon in the middle of the supraspinatus of the patient's shoulder.Rx was performed which confirmed the presence of the fragment (millimetre).The impact it will have on the patient is unknown, in relation to carrying out magnetic resonance imaging in the future.

• Brand Name: MULTIFIRE SCORPION NEEDLE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: jared engle ; 8009337001
• MDR Report Key: 19018334
• Report Number: 1220246-2024-01768
• Device Sequence Number: 3809769
• Product Code: MDM
• UDI-Device Identifier: 00888867283985
• UDI-Public: 00888867283985
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2024

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
• Operator of Device: Health Professional
• Device Model Number: MULTIFIRE SCORPION NEEDLE
• Device Catalogue Number: AR-13995N-1
• Device Lot Number: 15112007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 04/02/2024; 05/14/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/01/2024; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown