MAUDE Adverse Event Report: ARTHREX, INC. PIVOTPOST & CLAMP; OPERATING ROOM TABLE ACCESS

Model Number	PIVOTPOST & CLAMP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/19/2024, it was reported by a sales representative via sems-06739377 that an ar-1560 pivot post and clamp had the piece that makes it swivel break off.No further information was provided.This was discovered during a procedure.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged, ar-1560-02 & ar-1560-03.Pivot post and clamp, serial/batch number: (b)(6), was received for investigation.Visual evaluation noted that the adjustment knob was broken off.Functional testing of the ar-1560-02 was not conducted due to the damage to the rotation lever.It was noted that the pivotpost clamp was not damaged and functioned as intended.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• Brand Name: PIVOTPOST & CLAMP
• 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: 21157616
• Report Number: 1220246-2025-09463
• Device Sequence Number: 8419532
• Product Code: BWN
• UDI-Device Identifier: 00888867095182
• UDI-Public: (01)00888867095182(11)240827(10)012434
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 03/04/2025

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: PIVOTPOST & CLAMP
• Device Catalogue Number: AR-1560
• Device Lot Number: 012434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2024
• 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