MAUDE Adverse Event Report: ARTHREX, INC. IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2024
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 9/17/2024, it was reported by a sales representative via email that the swivelock anchor from an ar-1593-bc secondary fixation implant system pulled out of the medial condyle.This was discovered during an mcl procedure on (b)(6) 2024.The case was completed using a 5.5 mm swivelock.Additional information received on 9/23/2024: the case was delayed about an hour, and additional anesthesia was used.The case was completed using an ar-7221 fiberwire.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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 a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
• 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: 20292840
• Report Number: 1220246-2024-07824
• Device Sequence Number: 7200061
• Product Code: MAI
• UDI-Device Identifier: 00888867331310
• UDI-Public: (01)00888867331310(11)240626(17)280531(10)15278721
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
• Device Catalogue Number: AR-1593-BC
• Device Lot Number: 15278721
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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