MAUDE Adverse Event Report: ARTHREX, INC. IMPACTOR PAD; MANUAL INSTR, GENERAL SURGICAL

Model Number	IMPACTOR PAD
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
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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
One unpackaged 0837-000 impactor pad lot number: 210546 was received for investigation.Visual inspection of the device noted significant wear and tear damage, with multiple dents and scratches on the surface and slight discoloration of the device along with faded laser markings.The most likely cause for this can be attributed to wear and tear incurred from repeated use.Manufactured date: 28-jun-2021.The complaint device was further visually inspected under a magnifier and damage was noted to the thread of the device.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to excessive force/friction during use.Complaint allegation is confirmed.

• Brand Name: IMPACTOR PAD
• 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: 19632471
• Report Number: 1220246-2024-06492
• Device Sequence Number: 8793845
• Product Code: LXH
• UDI-Device Identifier: 00848665013559
• UDI-Public: 00848665013559
• 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): 09/23/2024

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: IMPACTOR PAD
• Device Catalogue Number: 0837-000
• Device Lot Number: 210546
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown