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

Model Number	SUTURE ANCHOR, PEEK PUSHLOCK
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per wi-000101075 rev.24.0, product history reviews are required for all complaints classified as an early warning or adverse event and any complaint where investigation reveals a confirmed cause category of design, process, product, or supplier.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to applying excessive user applied mechanical forces upon insertion.
Event or Problem Description
It was reported that during a labrum refixation shoulder surgery the thread lost contact with the anchor and moved deeper into the anchor although the applied impact force was controlled.This caused the thicker part of the rod to move into the anchor and spread it open.The round metallic impact plate with approx.1 cm diameter had no stable connection to the rod or tube.No part of the device broke.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with the two affected devices, although these were damaged.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: SUTURE ANCHOR, PEEK PUSHLOCK
• 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: 19276929
• Report Number: 1220246-2024-02995
• Device Sequence Number: 7592270
• Product Code: HWC
• UDI-Device Identifier: 00888867023147
• UDI-Public: 00888867023147
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• 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): 05/09/2024

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: 11/30/2025
• Device Model Number: SUTURE ANCHOR, PEEK PUSHLOCK
• Device Catalogue Number: AR-1923PS
• Device Lot Number: 12359833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2020
• 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