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	01/29/2026
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 10th march 2026, it was reported by an arthrex's employee via an email that for 1 unit of ar-1370p, peek interference screw, sheathed, 7 x 23 mm, its anchor broke during insertion.This was detected during an anterior cruciate ligament reconstruction surgery on (b)(6) 2026.The procedure was completed successfully by using another new ar-1370p.There were no patient harm and no secondary procedure needed.

• 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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24716544
• Report Number: 1220246-2026-01718
• Device Sequence Number: 5989360
• Product Code: MAI
• UDI-Device Identifier: 00888867014695
• UDI-Public: (01)00888867014695(11)230613(17)280531(10)15103977
• 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,Followup
• Report Date (Section B): 06/12/2026

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: 15103977
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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