MAUDE Adverse Event Report: ARTHREX, INC. MOTOR WITH CABLE 3.5M; POWERED SURG ORTHOPEDIC INSTR

Model Number	MOTOR WITH CABLE 3.5M
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a minimalinvasive distale metatarsal-osteotomie (dmmo) the handpiece was smoking while working on the patient with the ar-300b.The handpiece became very noisy and the burr also had dark grooves at the end.A redness had formed at the edges of the wound of the patient, which will be monitored.According to the surgeon the failure was not cased by the handpiece.The surgeon tried the other burr attachments on the same handpiece and these ran smoothly.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 20-jun-2024 it was confirmed that during use of the attachment ar-300b the handpiece got louder and smoke came from the attachment not the handpiece.The attachment ar-300b was partially black after use and the patient got burned.Wound edges were reddened.The burned parts could be removed with ablation.The handpiece was tested with different attachments and worked fine.Also, the affected attachment was tested with different shavers and all shavers became louder during use with the reported attachment.The handpiece will also be returned for investigation.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint is not confirmed, as no allegation against the ar-200m motor with cable 3.5 m, batch/serial (b)(6), was identified in the event summary.Based on the information provided and after reviewing the vendor evaluation result for the ar-300b, batch 05713, it is concluded that there is no allegation against the ar-200m motor with cable 3.5 m, batch/serial (b)(6).The device was working as intended after the customer functionally tested the ar-200m motor with cable 3.5 m, batch/serial (b)(6) with other ar-300b units in the field.No problem found.

• Brand Name: MOTOR WITH CABLE 3.5M
• 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: 19623444
• Report Number: 1220246-2024-06450
• Device Sequence Number: 6359359
• Product Code: HWE
• UDI-Device Identifier: 00888867200708
• UDI-Public: 00888867200708
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MOTOR WITH CABLE 3.5M
• Device Catalogue Number: AR-200M
• Device Lot Number: 15166301
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown