MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK SUTURE TAK; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, PEEK SUTURE TAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy the suture fell out of the anchor when the device was properly implanted.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (ar-1934ps-1, lot 13249303).It was not necessary to switch the surgical technique or do a second surgery.
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.The complaint is not confirmed.One unpackaged c18979-01 driver shaft along with an sp-02-02b and an sp-02-02w suture construct were received from an ar-1934ps-2-1.Visual inspection identified that the implant was not returned for analysis.No damage was noted to either suture construct or the driver shaft.No problem found.The allegation was unable to be replicated.

• Brand Name: SUTURE ANCHOR, PEEK SUTURE TAK
• 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: 19261331
• Report Number: 1220246-2024-02904
• Device Sequence Number: 6493263
• Product Code: MAI
• UDI-Device Identifier: 00888867024199
• UDI-Public: 00888867024199
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K140855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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: 01/31/2024
• Device Model Number: SUTURE ANCHOR, PEEK SUTURE TAK
• Device Catalogue Number: AR-1934PS-2-1
• Device Lot Number: 10280327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2019
• 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