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	Use of Device Problem (1670); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/14/2025, a sales representative reported via phone that an ar-1593-p secondary fixation with peek swivelock anchor implant system experienced an issue during use.The 4.75 mm swivelock peek anchor stopped threading, advancing approximately one-third to halfway through insertion, and began crushing.No pieces broke off into the patient.The procedure was completed using a replacement 4.75 mm swivelock anchor.The delay was less than 15 minutes, and no additional anesthesia was administered.This issue occurred during an acl procedure on (b)(6) 2025, with no reported patient harm.
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 the complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error.This includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking and/or being damaged.Directions for use (b)(4) - corkscrew, pushlock, and swivelock suture anchors.G.Precautions 3.Make sure to use the recommended drill bit or punch to create the bone socket.4.Pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.The complaint is confirmed based on the customer's attached picture, which shows the outside-molded shaft tip appears bent, indicating implant resistance; additionally, the anchor threads were warped and bent.

• 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: 23335092
• Report Number: 1220246-2025-04683
• Device Sequence Number: 13222880
• Product Code: MBI
• UDI-Device Identifier: 00888867331303
• UDI-Public: (01)00888867331303(11)250731(17)300531(10)15475569
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/17/2026

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: 15475569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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