MAUDE Adverse Event Report: ARTHREX, INC. SPKD LGMNT STAPLE 11 MMX 20 MMLG; STAPLE, FIXATION, BONE

Model Number	SPKD LGMNT STAPLE 11 MMX 20 MMLG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
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 10/25/2024, it was reported by an arthrex subsidiary employee via sems-06695106 that an ar-1011 spiked ligament staple broke.This occurred during an anterateral knee procedure on (b)(6) 2024 when the device broke.The fragment was removed.The case was completed with another product.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on the customer's attached picture, which shows an ar-1011 spiked ligament staple 11 x 20 mm broken into three pieces.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 that the allegation was confirmed on the ar-1011, and the reported failure is most likely related to a user error such as misaligned insertion, prying/leveraging, and/or applying excessive force on the device during use.

• Brand Name: SPKD LGMNT STAPLE 11 MMX 20 MMLG
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 20622083
• Report Number: 1220246-2024-08437
• Device Sequence Number: 8874199
• Product Code: JDR
• UDI-Device Identifier: 00888867002548
• UDI-Public: (01)00888867002548(11)230723(17)280531(10)118805
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K943492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: SPKD LGMNT STAPLE 11 MMX 20 MMLG
• Device Catalogue Number: AR-1011
• Device Lot Number: 118805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2023
• 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