MAUDE Adverse Event Report: ARTHREX, INC. SPRAYCLIP FOR AR-200; POWERED SURG ORTHOPEDIC INSTR

Model Number	SPRAYCLIP FOR AR-200
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No problem found.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude that there is no allegation against the ar-200sp, spray clip for ar-200.The device works as intended, and no problem was found.
Event or Problem Description
On 10th september 2024, it was reported by a sales representative via email that an ar-200m motor with cable 3.5m was heating up.This was detected during a total ankle replacement procedure on (b)(6) 2024.Dr.(b)(6) was doing a total ankle replacement +/- heel shift.Arthrex mis handpiece was on the setup for the +/- heel shift part of the procedure.After the case, the sales representative was told by the nursing staff that the arthrex mis handpiece had caused severe burns to the patient's thigh area.When the sales representative went to the theatre, he was told by the scout nurse that the scout nurse "accidentally plugged the arthrex mis handpiece into the synthes e-pen console because it fit in it perfectly".That caused the handpiece to heat up and melt through the holding quiver, causing the burns to the patient.Sales representative was told by the scrub nurse that no one noticed it heating up because the handpiece was not used during the case as heel shift was not required at the end.Sales representative's attendance was not required for this case as both nursing staff are trained and know how to plug in arthrex mis handpiece.Update on patient condition as of (b)(6) 2024: ¿ patient suffered a full thickness skin burn ¿ patient had a skin graft procedure yesterday and doing well ¿ the hand piece is going to be replaced.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-200sp sprayclip for ar-200, serial/batch number (b)(6) was received for evaluation.A visual inspection revealed that the device material was discolored, and a foreign material was adhered to the edges of the sprayclip, most likely the same material found in the body of the ar-200m, s/n (b)(6).Evaluation of the sprayclip rod found no damage.Arthrex concludes that there is no allegation against the ar-200sp sprayclip for ar-200, serial/batch number (b)(6); however, the device was found to have some damage.The cause of the observed device damage is related to the abnormal use of the ar-200m, s/n (b)(6) by plugging the ar-200m motor with cable 3.5 m handpiece into the synthes e-pen console.

• Brand Name: SPRAYCLIP FOR AR-200
• Common Device Name: POWERED SURG ORTHOPEDIC 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: 20396664
• Report Number: 1220246-2024-08027
• Device Sequence Number: 16988832
• Product Code: HWE
• UDI-Device Identifier: 00888867245822
• UDI-Public: 00888867245822
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: SPRAYCLIP FOR AR-200
• Device Catalogue Number: AR-200SP
• Device Lot Number: 15275875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown