MAUDE Adverse Event Report: ARTHREX, INC. SIDE RELEASE RETRO CONSTR HANDLE; MANUAL INSTR, GENERAL SURGICAL

Model Number	SIDE RELEASE RETRO CONSTR HANDLE
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/06/2025, it was reported by a sales representative via (b)(4) that an ar-1510hr retroconstruction drill guide handle knob pin fell out and knob came off.The patient was not affected.This was discovered during a procedure, with no reported patient harm.Additional information was received on 02/12/2025: this occurred during a acl/pcl procedure on (b)(6)2025.The knob was found but they could never find the pin.An x-ray was taken to make sure it wasn¿t in the patient.The case was completed using a new acl set and a ar-1510hr retroconstruction drill guide handle was used to complete the case.There was a twenty minute delay in the case.
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.Upon visual inspection, it was noted that the dowel pin is missing from device.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during tightening /untightening the knob.

• Brand Name: SIDE RELEASE RETRO CONSTR HANDLE
• 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: 21421539
• Report Number: 1220246-2025-00566
• Device Sequence Number: 18052921
• Product Code: MDM
• UDI-Device Identifier: 00888867196773
• UDI-Public: (01)00888867196773(11)240816(10)43212414
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/30/2025

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: SIDE RELEASE RETRO CONSTR HANDLE
• Device Catalogue Number: AR-1510HR
• Device Lot Number: 43212414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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