MAUDE Adverse Event Report: ARTHREX, INC. HANDLE, REPLACEMENT, SUCTION DOWNBITER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	HANDLE, REPLACEMENT, SUCTION DOWNBITER
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
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
It was reported that on the ar-6701 the suction punch is coroded.The ar-8330f with sn: (b)(6) the device has rust in the sealing cap.The ar-3240-5027 with sn: (b)(6) has an insufficient brightness through the cable to the optics.Furthermore, there is a tear at the distal end of the cable.The ar-3240-5027 with sn: (b)(6) has an insufficient brightness through the cable to the optics.The ar-400 with sn: (b)(6) is not working with two different batteries.The ar-3371-4000 is partly affected by rust in the lumens/cavities.There was no harm for patient, operator or third party reported.There was no case involvement reported.No further information received.
Additional Manufacturer Narrative
One unpackaged ar-6701 replacement handle for suction sidebiter batch number: 011940 was received for investigation.Visual evaluation noted wear and tear to the device with scratches and discoloration observed on the surface of the returned device.The cause for the reported failure can be attributed to wear and tear incurred from repeated usage/reprocessing.Date of manufacture: 10-oct-2019.

• Brand Name: HANDLE, REPLACEMENT, SUCTION DOWNBITER
• 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: 21150829
• Report Number: 1220246-2025-09446
• Device Sequence Number: 9330522
• Product Code: LXH
• UDI-Device Identifier: 00888867040779
• UDI-Public: 00888867040779
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: HANDLE, REPLACEMENT, SUCTION DOWNBITER
• Device Catalogue Number: AR-6701
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown