MAUDE Adverse Event Report: ARTHREX, INC. CENTRIFUGE, ROTOFIX 32, 110V

Model Number	CENTRIFUGE, ROTOFIX 32, 110V
Medical Device Problem Codes	No Device Output (1435); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2023, it was reported by a sales representative via sems that an abs-10020 centrifuge did not output any blood.This was discovered during a case with no patient effect.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation was not confirmed.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 a most likely cause.The reported failure is most likely due to a user error, following the correct surgical technique for the device.

• Brand Name: CENTRIFUGE, ROTOFIX 32, 110V
• Common Device Name: CENTRIFUGE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17380127
• Report Number: 1220246-2023-07298
• Device Sequence Number: 20363040
• Product Code: JQC
• UDI-Device Identifier: 00888867001879
• UDI-Public: 00888867001879
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: CENTRIFUGE, ROTOFIX 32, 110V
• Device Catalogue Number: ABS-10020
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown