MAUDE Adverse Event Report: ARTHREX, INC. EASY-OUT, MINI/STANDARD COMPRESSION FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	EASY-OUT, MINI/STANDARD COMPRESSION FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a foot surgery the tip broke off inside the patient.The broken pieces were retrieved from patient.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation was confirmed.One packaged ar-8737-62 batch 1391942 was received for evaluation.Visual inspection noted that the tip of the instrument threaded tip was broken off.No functional testing was performed as the instrument was broken off.Due to the breakage, the instrument's overall length is shorter.Drawing c15892 at revision 3 measurement: 4.4 ±.01 result: 4.29.The most likely cause of the reported failure is a user error, as mechanical damage to the device such as hitting the device with another device or object, prying/leveraging, or excessive bending forces applied during use.

• Brand Name: EASY-OUT, MINI/STANDARD COMPRESSION FT
• 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: 20011328
• Report Number: 1220246-2024-07186
• Device Sequence Number: 4362948
• Product Code: LXH
• UDI-Device Identifier: 00888867263833
• UDI-Public: 00888867263833
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: EASY-OUT, MINI/STANDARD COMPRESSION FT
• Device Catalogue Number: AR-8737-62
• Device Lot Number: 1391942
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown