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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint allegation cannot be confirmed without the device for evaluation.The device was not received for evaluation, and no photos of the failure were provided.Per the event description, the most likely cause(s) for the reported failure can be attributed to user error, improper bone preparation, misaligned insertion.
Event or Problem Description
It was reported that during an acl btb procedure, when the surgeon impacted the ar-1011, it twisted.A couple of attempts were made to reattach it but it would not work.The case was completed by using a new ar-1011.

• 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: 19568889
• Report Number: 1220246-2024-06180
• Device Sequence Number: 15192224
• Product Code: JDR
• UDI-Device Identifier: 00888867002548
• UDI-Public: 00888867002548
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: SPKD LGMNT STAPLE 11 MMX 20 MMLG
• Device Catalogue Number: AR-1011
• Device Lot Number: 2041002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2020
• 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