MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that (3) ar-2922ps peek pushlock anchors broke at the same spot each time.This was discovered during a revision posterior labral repair on (b)(6) 2022.Additional information received on (b)(6) 2022: all broken fragments from the three pushlock's were removed.Case was completed with another ar-2922ps peek pushlock.During this revision surgery, only the pushlock was implanted, and nothing was explanted.Sales representative cannot confirm any informant regarding the original surgery, as it was performed by another surgeon.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.The complaint is confirmed based on the customer provided photo, which shows that the implants broke.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation and/or misaligned insertion.

• Brand Name: SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16120376
• Report Number: 1220246-2023-06039
• Device Sequence Number: 5846731
• Product Code: MAI
• UDI-Device Identifier: 00888867027992
• UDI-Public: 00888867027992
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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 Model Number: SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK
• Device Catalogue Number: AR-2922PS
• Device Lot Number: 15005887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown