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 Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a sales representative reported via email that an ar-1593-p secondary fixation implant system with peek swivelock anchor (4.75 x 19.1) would not go into the bone and subsequently broke.This was discovered during a procedure on (b)(6) 2026.The patient outcome was not reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50544414
• Report Number: 1220246-2026-04556
• Device Sequence Number: 10312266
• Product Code: MBI
• UDI-Device Identifier: 00888867331303
• UDI-Public: (01)00888867331303(11)260423(17)301231(10)15611224
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 09/01/2026

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: 15611224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2026
• 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