MAUDE Adverse Event Report: ARTHREX, INC. LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
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.Visual inspection found that the handle has broken off the device.Complaint was confirmed.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces.
Event or Problem Description
On 02/09/2022, it was reported by a facility representative via sems that an ar-1665bcsl lnt implant system, 4.75 bc swivelock completely broke off from the attached handle during a surgical case on (b)(6) 2022.There was no harm to the patient, no pieces broke off inside the patient, and the surgical case was completed as planned.This was discovered during use with no impact to the patient.Additional information was requested.On 02/15/2022, the following additional information was provided: the procedure was a right shoulder arthroscopy biceps tenodesis.The device did not break inside the patient, the device broke while using it, leaving the metal tip sticking out of the patient.Nothing was left in the patient.The procedure was completed as planned, no harm to the patient, no impact, a possible 5 minute delay.

• Brand Name: LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 19327238
• Report Number: 1220246-2024-03356
• Device Sequence Number: 15181063
• Product Code: MAI
• UDI-Device Identifier: 00888867367265
• UDI-Public: 00888867367265
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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 Expiration Date: 01/31/2025
• Device Model Number: LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK
• Device Catalogue Number: AR-1665BCSL
• Device Lot Number: 13542222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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