MAUDE Adverse Event Report: ARTHREX, INC. PEEK INTERF SCRW W/DISP SHTH 6X 23MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK INTERF SCRW W/DISP SHTH 6X 23MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
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 (b)(6) 2024 , it was reported by an arthrex employee via email that an ar-1360p, peek interference screw, sheathed, 6 x 23 mm broke during insertion.This was detected during a patellar ligament reconstruction surgery on (b)(6) 2024.Anchor was inserted easily but it was found broken at the end.All fragments were retrieved from patient.Procedure was successfully completed with no patient harm and no secondary procedure needed by using another new ar-1360p.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1360p peek interference screw was received for investigation.The disposable sheath was not returned for investigation.Visual evaluation of the returned device noted a small nick to the surface of the device near the tip.Small scratches were also observed near the screw hex drive.The returned ar-1360p peek interference screw was not observed to be broken and was intact.Dimensional testing was performed and the length was measured with a caliper.The length of the returned device was found to be.901 which is in tolerance of the dimension specified in drawing c1508 of.906 +.005 -.015.Functional testing was not able to be performed due to the missing component.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.Refer to investigation photos.

• Brand Name: PEEK INTERF SCRW W/DISP SHTH 6X 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: 21036741
• Report Number: 1220246-2024-09122
• Device Sequence Number: 18035703
• Product Code: MAI
• UDI-Device Identifier: 00888867014039
• UDI-Public: (01)00888867014039(11)230503(17)280430(10)15087811
• 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): 04/21/2025

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 6X 23MM
• Device Catalogue Number: AR-1360P
• Device Lot Number: 15087811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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