MAUDE Adverse Event Report: Arthrex, Inc. PEEK INTERF SCRW W/DISP SHTH 7X 23MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK INTERF SCRW W/DISP SHTH 7X 23MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 3rd september 2026, it was reported by an arthrex's employee via an email that 1 unit of ar-1370p, peek interference screw, sheathed, 7 x 23 mm, was fractured.This was detected during an arthroscopic left knee joint exploration + synovectomy + harvest of peroneus longus tendon, acl revision and reconstruction on 13th august 2026.The procedure was completed successfully by using a new ar-1370p for the fixation.There were no patient harm and no secondary surgery needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: PEEK INTERF SCRW W/DISP SHTH 7X 23MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 50802265
• Report Number: 1220246-2026-04775
• Device Sequence Number: 21469847
• Product Code: MAI
• UDI-Device Identifier: 00888867014695
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: PEEK INTERF SCRW W/DISP SHTH 7X 23MM
• Device Catalogue Number: AR-1370P
• Device Lot Number: 15323537
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown