MAUDE Adverse Event Report: ARTHREX, INC. HINDFOOT NAIL, IMPACTION ROD; ORTHOPEDIC MANUAL SURG INSTR

Model Number	HINDFOOT NAIL, IMPACTION ROD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/24/2024, it was reported by a sales representative via (b)(4) that an ar-9091-01 hindfoot nail targeting guide cracked at the interface of the attachment piece for the nail, an ar-9091-31 hindfoot nail snapped off, and an ar-9091-26 torque limiter slides up and down the shaft of the driver itself making it unusable.This occurred during a 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: b5, d9, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information provided on 11/13/2024 by a sales representative who stated the event occurred on (b)(6) 2024 and the procedure performed was a hindfoot fusion.The impactor pad snapped off in the targeter during impaction of the nail.An arthrex rep was present during the case.The patient's bone quality was average.No fragments broke off in the patient.There was no additional anesthesia needed and no delay to the procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9091-31 with serial/batch number (b)(6) was received for evaluation.Upon visual inspection it was discovered that the tip of the device was broken off.Damaged was observed on the handle and laser marks degradation.The most likely cause of the reported failure is a use/technique error.This includes factors such as misaligned insertion, prying/leveraging, and/or applying excessive force on the device during use.

• Brand Name: HINDFOOT NAIL, IMPACTION ROD
• 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: 20687070
• Report Number: 1220246-2024-08535
• Device Sequence Number: 7281607
• Product Code: LXH
• UDI-Device Identifier: 00888867334922
• UDI-Public: (01)00888867334922(11)231024(10)37982342
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 01/28/2025

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: HINDFOOT NAIL, IMPACTION ROD
• Device Catalogue Number: AR-9091-31
• Device Lot Number: 37982342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 11/13/2024; 01/03/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/20/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2023
• 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