MAUDE Adverse Event Report: ARTHREX, INC. EASYOUT EXTRACTOR; MANUAL INSTR, GENERAL SURGICAL

Model Number	EASYOUT EXTRACTOR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/31/2024 a sales representative reported via (b)(4) that a 0812-100 easyout extractor and an 0837-000 impactor pad were threaded into the extraction tool, and when the surgeon was removing the implant, metal shavings were everywhere from both pieces.This was discovered during a procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 6/4/2024: the metal shavings did not go inside the patient but just into the sterile field.All metal shavings were removed from the sterile field, and the case was completed.There was no case delay.This was discovered during a tibial nail removal procedure.The issue had no adverse effects on the patient.
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 unpackaged 0812-100, batch/serial number (b)(6), was received for evaluation.The device was received attached to the 0837-000.Upon visual inspection, the thread of the easyout extractor 0837-000 was damaged, which is a possible reason why the device became stuck in the nail.Damage/scratches was observed on the device.Functional testing was not performed as the device was damaged and is stuck inside the 0837-000.The most probable reason for the reported malfunction is user error.It is crucial to make sure that when two devices are meant to be threaded together, they are completely engaged prior to use.

• Brand Name: EASYOUT EXTRACTOR
• 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: 19632421
• Report Number: 1220246-2024-06491
• Device Sequence Number: 15240403
• Product Code: LXH
• UDI-Device Identifier: 00848665002447
• UDI-Public: 00848665002447
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/25/2024

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: EASYOUT EXTRACTOR
• Device Catalogue Number: 0812-100
• Device Lot Number: 130034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown