MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-1927psf-3 suture fragment (no batch indicator provided) was received for investigation.It was identified using calibrated ruler id: 651 that approximately 21.1" of suture was returned, with thread breakage noted at the 15.4" mark.The observed condition of the device is most likely the result of user applied excessive force and/or through nicking the suture against instrumentation/sharp bone.
Event or Problem Description
It was reported that during arthroscopy the suture did rip off at the suture attachment while trying to pull the anchor.The broken off piece has been retrieved from the patient.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information received.Update, 11-may-2021 -sac received further information that the anchor has already been fully inserted when the thread did rip off.

• Brand Name: SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 19569823
• Report Number: 1220246-2024-06196
• Device Sequence Number: 17718544
• Product Code: MBI
• UDI-Device Identifier: 00888867023642
• UDI-Public: 00888867023642
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143745
• 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): 06/19/2024

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 Expiration Date: 12/31/2025
• Device Model Number: SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
• Device Catalogue Number: AR-1927PSF-3
• Device Lot Number: 12534412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• 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