MAUDE Adverse Event Report: ARTHREX, INC. WRKST BUSHING ALOGFT OATS,22.5MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	ALLOGRAFT OATS WORKSTATION BUSHING 22MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
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
On 05/09/2024 it was reported by a arthrex employee via (b)(4) that an ar-4081-225 allograft oats bushing is producing debris when in use.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-4081-22 serial/batch number (b)(6) was received for investigation.Visual inspection of the returned device revealed discoloration spots, faded laser marks.Scratches outside and inside the diameter the reported failure may be due to wear and tear from prolonged use in the field, as the device shows significant signs of wear and tear.

• Brand Name: WRKST BUSHING ALOGFT OATS,22.5MM
• 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: 19475202
• Report Number: 1220246-2024-05021
• Device Sequence Number: 3981780
• Product Code: LXH
• UDI-Device Identifier: 00888867032279
• UDI-Public: 00888867032279
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: ALLOGRAFT OATS WORKSTATION BUSHING 22MM
• Device Catalogue Number: AR-4081-225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 09/19/2024
• 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