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

Model Number	SCORPION-MULTIFIRE NEEDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event description, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error.This includes striking bone or applying excessive force when attempting to pass the needle through fibrous or calcified tissue, as noted in the directions for use (dfu-0392-sub-eo, warning for scorpion products).Additional contributing factors may include excessive force used to pass the needle through the scorpion instrument or failure to inspect the instrument prior to use, as outlined in the directions for use (dfu-0255-eo) for arthrex hand instruments.E.Inspection and maintenance: 1.Arthrex instruments are precision medical instruments and must be used and handled with care.Inspect the instruments for damage prior to use and at all stages of handling thereafter.If damage is detected, do not use the device prior to consulting the manufacturer for guidance.2.Pre- use inspection criteria a.Hand operation functional test without the use of excessive force, squeeze handles together and verify the jaw and tip squarely meet with no visible gaps when closed.Spread handles apart and verify the movement is free and non-restrictive and that movement is seen at the distal end.Repeat two times minimum.Verify devices with cutting ability and sharpness of points and edges.B.Distal end integrity visual inspection: i.Devices with cutting functions or sharp points become dull with continuous use.This condition does not indicate a device defect.This condition indicates normal wear.Dull devices may require replacement or discard if they no longer perform as designed.Inspection prior to use should include verifying the cutting ability and sharpness of these points and edges.Directions for use (dfu-0392-sub).Warning.To help avoid needle breakage and potential patient injury: 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.Since the complaint device was not returned and no evidence of the failure was provided, neither physical inspection nor a review of images could be performed.As a result, the complaint allegation could not be confirmed.
Event or Problem Description
On 24th march 2026, it was reported by an arthrex's employee via an email that for 1 unit of ar-13995n, multifire¿ scorpion¿ needle, approximately 2mm of the tip was missing.This was detected during an arthroscopic rotator cuff suture surgery on (b)(6) 2026.The surgeon searched around the surgical field and attempted to find and remove it under the arthroscopy but failed.Using the c-arm fluoroscopy, it was found that there was about 1mm * 22mm foreign object.It was considered to be caused by the thickness of the tendon during the tendon suture process and they suspected that it was due to the weakness point of the inner core breaking.Through x-ray fluoroscopy, it was determined that the foreign object remained under the acromion.The arthroscopy fully explored the upper and lower surfaces of the tendon but could not find the broken part of the inner core.Combined with repeated fluoroscopic examinations during the operation, it was considered that the foreign object was inside the tendon and stable.After discussion among the doctors of the surgical team, forcibly removing the foreign object would cause significant damage to the tendon, hence the decision for removal was abandoned.The procedure was completed but the broken piece was left inside the patient.Additional information: it was during the process of suturing the rotator cuff with the rotator cuff suture gun where the scrub nurse checked that the ar-13995n (inner core) was missing approximately 2mm at the tip when compared with a normal inner core.

• Brand Name: SCORPION-MULTIFIRE 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: 24844413
• Report Number: 1220246-2026-02141
• Device Sequence Number: 5623901
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: (01)00888867015951(11)241217(17)291130(10)15363304
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/10/2026

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-MULTIFIRE NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 15363304
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown