MAUDE Adverse Event Report: ARTHREX, INC. IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via email that an ar-1593-p secondary fixation with peek swivelock anchor implant system experienced anchor breakage upon insertion despite following the correct technique.No adverse effects on the patient were reported.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 08/15/2025: the event occurred during a btb acl procedure on (b)(6) 2025 involving secondary fixation.The anchor did not fracture; however, the eyelet and anchor detached from the inserter, which bent during insertion.Both the eyelet and screw were successfully removed from the patient.The surgeon elected to forgo secondary fixation and completed the procedure by tying knots, with no additional components used following the failure of the ar-1593-p.No significant case delay or additional anesthesia was reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 22902337
• Report Number: 1220246-2025-03656
• Device Sequence Number: 7932748
• Product Code: MBI
• UDI-Device Identifier: 00888867331303
• UDI-Public: (01)00888867331303(11)250529(17)300430(10)15443781
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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 PEEKSWVLK 4.75X19.1
• Device Catalogue Number: AR-1593-P
• Device Lot Number: 15443781
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown