MAUDE Adverse Event Report: ARTHREX, INC. OUTRIGGER TARGETING GUIDE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	OUTRIGGER TARGETING GUIDE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 8th october 2024, it was reported by a sales rep.Via email that for an ar-8973-01, outrigger targeting guide, the tip cracked and chipped off due to excessive torque.This was detected during use in a fibulock nail removal procedure on (b)(6) 2024.The client tried to use ar-8973-01 to remove an implanted fibulock nail after failure of ar-8973rk to remove the nail.The procedure was aborted.All fragments were collected and no pieces were left in the patient.9th october 2024 - the sales rep replied that there was no defect with ar-8973rk, the implant was just stuck and could not be removed.It was an elective removal with no medical indication, so the surgeon ended up deciding to leave it in the patient as it was not causing them any harm.
Event or Problem Description
On 10th october 2024: the sales rep.Updated that when ar-8973rk was being used to remove the nail nothing broke and everything was intact and the nail was simply incorporated into the bone too tightly to be removed.There is no follow-up surgery planned to complete the procedure as the patient was already counseled prior to surgery about the possibility of leaving the nail in place as there was no medical indication for implant removal.There were no medical issues.The nail was implanted in a way that a part of it was prominent, which bothered the patient which was the reason for the surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse due to excessive user-applied mechanical forces.

• Brand Name: OUTRIGGER TARGETING GUIDE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 20410508
• Report Number: 1220246-2024-08054
• Device Sequence Number: 9104875
• Product Code: LXH
• UDI-Device Identifier: 00888867301832
• UDI-Public: (01)00888867301832(11)190521(10)711920
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2025

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: OUTRIGGER TARGETING GUIDE
• Device Catalogue Number: AR-8973-01
• Device Lot Number: 711920
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 08/15/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/25/2024; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2019
• 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