MAUDE Adverse Event Report: ARTHREX, INC. LEG HOLDER, LOW PROFILE; OPERATING ROOM TABLE ACCESS

Model Number	LEG HOLDER, LOW PROFILE
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, according to pictures, the leg holder shows signs of wear and tear.There was no harm for patient, operator or third party reported.There was no case involvement reported.No further information received.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Corrections: h.1 set as n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.
Event or Problem Description
Update, (khe), (b)(6) 2024 further information received.The event was occurred during the reprocessing.

• Brand Name: LEG HOLDER, LOW PROFILE
• Common Device Name: OPERATING ROOM TABLE ACCESS
• 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: 19791799
• Report Number: 1220246-2024-06812
• Device Sequence Number: 4197996
• Product Code: BWN
• UDI-Device Identifier: 00888867018204
• UDI-Public: 00888867018204
• 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: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

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: LEG HOLDER, LOW PROFILE
• Device Catalogue Number: AR-1500
• Device Lot Number: 00301.14
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown