MAUDE Adverse Event Report: ARTHREX, INC. PEEK INTERF SCRW W/DISP SHTH 8X 23MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK INTERF SCRW W/DISP SHTH 8X 23MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by an arthrex employee via email that for an ar-1380p, peek interference screw, sheathed, 8 x 23 mm, the anchor broke during insertion.This was detected during a anterior cruciate ligament reconstruction of knee joint surgery on (b)(6) 2024.There was no patient harm and no secondary procedure needed.The procedure was completed successfully as another new ar-1380p was used.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1380p, peek interference screw, sheathed, 8 x 23 mm, batch: 15132542, was received for investigation.Functional testing was not able to be performed due to the damage to the device.Upon visual evaluation, the screw was broken and is coming apart at multiple of the twists.The method used to prepare the bone, as well as the bone quality encountered during the procedure, were not provided.The most likely cause can be attributed misuse due to improper bone preparation; misaligned insertion; or prying/leveraging the screw during insertion.

• Brand Name: PEEK INTERF SCRW W/DISP SHTH 8X 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: 20789219
• Report Number: 1220246-2024-08646
• Device Sequence Number: 12736394
• Product Code: MAI
• UDI-Device Identifier: 00888867015326
• UDI-Public: (01)00888867015326(11)230823(17)280731(10)15132542
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: PEEK INTERF SCRW W/DISP SHTH 8X 23MM
• Device Catalogue Number: AR-1380P
• Device Lot Number: 15132542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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