MAUDE Adverse Event Report: ARTHREX, INC. KEYHOLE GUIDE, LEFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	KEYHOLE GUIDE, LEFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via (b)(4) that an ar-13417-01 keyhole guide broke inside the patient.This occurred during use in a case, the device was unknowingly left inside the patient and a revision surgery was needed to remove.Per facility: "on friday (b)(6)2025 {surgeon} performed an inbalance hto at {hospital} with loaner instrument set from order number (b)(4).In performing the case we didn't realize that the left sided keyhole guide (ar-13417-01) posterior leg broke for an unknown reason.Unfortunately, this was not caught during the rest of the case until the following morning (b)(6)2025 when {surgeon} was rounding on the patient in the hospital when they performed an x-ray and found the broken piece.The photos are attached.We then performed a 2nd surgery on this patient for removal of the retained hardware saturday 2/8/25.Although we do not have a great reason for why the instrument broke, we did notice the instrument was much more ¿weathered¿ and older than the right sided key-hole drill guide.{surgeon} was very understanding and in hindsight, we should have recognized the broken piece in x-rays taken during the rest of the case.The removal of the hardware was quick and the broken piece was collected, washed and put back in the tray for your examination.".
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged, ar-13417-01, keyhole guide, left, serial/batch number (b)(6), was received for investigation.Visual inspection noted severe surface damage: oxidation, fading and abrasion marks.Additionally, a fragment of the device was broken off.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure is attributed to wear and tear due to repeated use.The manufacturing date of the device was 2011.

• Brand Name: KEYHOLE GUIDE, LEFT
• 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: 21445187
• Report Number: 1220246-2025-00608
• Device Sequence Number: 7780507
• Product Code: MDM
• UDI-Device Identifier: 00888867012431
• UDI-Public: 00888867012431
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KEYHOLE GUIDE, LEFT
• Device Catalogue Number: AR-13417-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/14/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown