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

Model Number	SUREFIRE SCORPION NEEDLE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); Foreign Body In Patient (2687)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07-may-2026, an arthrex subsidiary employee reported via (b)(4) that an ar-13991n surefire¿ scorpion¿ needle does not pass through.This occurred during an arthroscopic acromioplasty surgery of the right shoulder the physician placed the first stitch, inspected the tip of the scorpion needle, and confirmed it was intact.The physician then sutured the rotator cuff.The first stitch passed through the tissue smoothly, and the needle remained intact.During the attempt to place the second stitch, the physician grasped very thick tissue, and the needle did not pass through.The surgical support staff requested that the physician remove the forceps with the scorpion needle to reposition the stitch.The physician attempted to pass the needle an additional two times.When the forceps were finally removed to reinsert the suture, the support staff verified the needle tip and found it fractured.It was determined that the tip had broken off inside the patient, and the physician was immediately notified.No replacement needle was available to continue the procedure.As a result, the physician modified the surgical approach and converted the procedure to an open technique in order to suture the rotator cuff.A device from another manufacturer was utilized to complete the procedure.The broken needle tip could not be visualized or retrieved arthroscopically.It was noted that the patient has mild osteoporosis.Due to conversion to an open procedure, additional anesthesia was required for approximately 30 minutes, and a larger incision than originally planned was made.
Additional Manufacturer Narrative
The device associated with the reported event was not returned for evaluation.Based on the documented event information, which may include the returned device (if available), photographs, videos, event descriptions, and any additional field data, the most likely cause(s) of the reported device breakage are attributed to use error, including: device loading issues: improper loading of the suture or incorrect handling of the scorpion device may place abnormal stress on the needle.Contact with bone (refer to dfu-0392-sub-eo, revision 1).Application of excessive force when passing the needle through fibrous or calcific tissue (refer to dfu-0392-sub-eo, revision 1).The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: SUREFIRE 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: 25277320
• Report Number: 1220246-2026-02978
• Device Sequence Number: 13183039
• Product Code: MDM
• UDI-Device Identifier: 00888867015920
• UDI-Public: (01)00888867015920(11)250616(17)300531(10)15451806
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 05/26/2026

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
• Operator of Device: Health Professional
• Device Model Number: SUREFIRE SCORPION NEEDLE
• Device Catalogue Number: AR-13991N
• Device Lot Number: 15451806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown