MAUDE Adverse Event Report: ARTHREX, INC. SCORPION NEEDLE, CAPSULECLOSE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SCORPION NEEDLE, CAPSULECLOSE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 01/21/2025, a sales representative reported via sems-(b)(4) that an ar-16992 capsuleclose scorpion was bending the ar-16992n scorpion needle and twisting the suture every time it was fired.Nothing broke inside the patient.No case delay was reported, and it is unknown if added anesthesia was administered.The case was completed using another ar-16992 capsuleclose scorpion.No photos were taken of the issue.This was discovered during a hip labral repair procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 01/24/2025: a (qty.2) of an ar-16992n scorpion needle was used in the procedure.Both needles did not break inside the casing; they only bent.The part and lot number of the fiberwire used in the procedure are unknown.There were no adverse effects on the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device ar-16992n (bent needle) was not received for evaluation.Based on the evaluation of the received device (ar-16992, batch number 12650590) and the functional testing results, it is concluded that the most likely cause of the reported failure was user error, including reuse of the suture passer needle and the application of excessive force to pass the needle through fibrous or calcified tissue.Directions for use dfu-0392-sub-eo warning.Do not resterilize or reuse the scorpion¿ suture passer needle.Avoid striking bone or using excessive force to pass the needle through fibrous/calcific tissue.If excessive force is encountered, replace the needle, reposition the device and pass in a different area.Ensure a secure grasp of tissue to prevent the needle from buckling under the tissue.Avoid ¿dry¿ repetitive actuations outside the surgical site.Abrasion of the needle surface can occur that may inhibit proper function.The complaint allegation could not be confirmed.The claim that the ar-16992 capsule close scorpion (batch 12650590) bent the needles and twisted the suture could not be replicated during testing using a new needle.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation could not be confirmed.The claim that the ar-16992 capsule close scorpion (batch 12650590) bent the needles and twisted the suture could not be replicated during testing using a new needle.The complaint device ar-16992n (bent needle) was not received for evaluation.Based on the evaluation of the received device (ar-16992, batch number 12650590) and the functional testing results, it is concluded that the most likely cause of the reported failure was user error, including reuse of the suture passer needle and the application of excessive force to pass the needle through fibrous or calcified tissue.

• Brand Name: SCORPION NEEDLE, CAPSULECLOSE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21366402
• Report Number: 1220246-2025-00412
• Device Sequence Number: 8434938
• Product Code: LXH
• UDI-Device Identifier: 00888867219557
• UDI-Public: 00888867219557
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2025

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: SCORPION NEEDLE, CAPSULECLOSE
• Device Catalogue Number: AR-16992N
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 08/13/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 08/14/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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