MAUDE Adverse Event Report: ARTHREX, INC. DW CART; MANUAL INSTR, GENERAL SURGICAL

Model Number	DW CART
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 05/21/2024 it was reported by a sales representative via (b)(4) that an ar-6481 dw cart could not support four bags of saline -"when they put 4 bags of saline onto the hooks the iv pole collapses can't support 4 bags, safety risk for staff." this was discovered during a procedure with no patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, dw cart, ar-6481, batch 087388, was received for evaluation.Visual inspection noted signs of wear: oxidizing, peeling and denting.Functional testing found that when the pole was screwed into place, there was resistance moving it downwards and it would lock into place not moving in either direction.The complaint allegation could not be replicated, although it is likely related.The most likely cause for the reported failure is a wear and tear.

• Brand Name: DW CART
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19554188
• Report Number: 1220246-2024-05895
• Device Sequence Number: 6716420
• Product Code: MDM
• UDI-Device Identifier: 00888867039407
• UDI-Public: 00888867039407
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: DW CART
• Device Catalogue Number: AR-6481
• Device Lot Number: 087388
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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