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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/09/2024, it was reported by a sales representative via (b)(4) that an ar-200m motor with cable is not sealing and leaking blood from the housing where the clip is located to lock the burr attachment into place.The facility attempted to clean device for 2+ hours with no avail.This occurred after use in 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
Complaint allegation is confirmed.One unpackaged ar-200m serial/batch number (b)(6) was received for investigation.Functional testing could not be conducted due to the absence of the necessary mating part for testing.A visual inspection revealed signs of wear and tear.The evaluation of the customer's provided pictures substantiates the claim of leakage.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• 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: 19249361
• Report Number: 1220246-2024-02826
• Device Sequence Number: 12409784
• Product Code: HWE
• UDI-Device Identifier: 00888867200708
• UDI-Public: 00888867200708
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/29/2024

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: MOTOR WITH CABLE 3.5M
• Device Catalogue Number: AR-200M
• Device Lot Number: 15135737
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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