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

Model Number	SUTURE ANCHOR, CORKSCREW
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
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.Upon visual inspection, it was noted that only the inserters for the device were received.The anchors were not returned for investigation.Due to the anchors not returning, the complaint cannot be confirmed.
Event or Problem Description
It was reported that during a distal biceps tenodesis surgery the device could not be screwed into the drill hole, as the body of the anchor was damaged / bent during insertion.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 new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 28-mar-2022: it was confirmed that 2x ar-1920sf (lot 12990795) are affected in this case and the device ar-1915sf with the lot 12943197 was falsely reported.

• Brand Name: SUTURE ANCHOR, CORKSCREW
• 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: 19392033
• Report Number: 1220246-2024-03852
• Device Sequence Number: 7753688
• Product Code: HWC
• UDI-Device Identifier: 00888867022829
• UDI-Public: 00888867022829
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• 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
• Report Date (Section B): 05/24/2024

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: 02/28/2026
• Device Model Number: SUTURE ANCHOR, CORKSCREW
• Device Catalogue Number: AR-1920SF
• Device Lot Number: 12990795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown