MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation 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.
Event or Problem Description
On 12/20/2022, 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 12/20/2022: 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.No further information has been provided.

• Brand Name: SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 19792370
• Report Number: 1220246-2024-06838
• Device Sequence Number: 4133862
• 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): 08/14/2024

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: 14999475
• 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: 07/15/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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