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

Model Number	LEG HOLDER, LOW PROFILE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the belt and velcro closure need to be replaced.There was no harm for the patient, operator or third party reported.Also there was no case involvement reported.No further information received.
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: b5, d9, g3, h6.Event description: it was reported that the belt and velcro closure need to be replaced.The reported event was confirmed.The supplier evaluation revealed damages at the velcro which are most likely resulting from repeated use.Correction, h1 to 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 from 18-jun-2024.The velcro fastener did not come undone during a surgery.There was also no harm to a patient.According to the information from the customer, this is a preventive repair only.

• 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: 19498195
• Report Number: 1220246-2024-05385
• Device Sequence Number: 6661160
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 03004.98
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/11/2024
• 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