MAUDE Adverse Event Report: ARTHREX, INC. 2.9MM BIOCOMPOSITE PUSHLOCK KIT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	2.9MM BIOCOMPOSITE PUSHLOCK KIT
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ar-2923bc-k, indicator label is missing.
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.Complaint confirmed, the device was returned without a temperature sticker.See ncr-17709.

• Brand Name: 2.9MM BIOCOMPOSITE PUSHLOCK KIT
• 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: 19212071
• Report Number: 1220246-2024-02596
• Device Sequence Number: 17877939
• Product Code: MAI
• UDI-Device Identifier: 00888867224117
• UDI-Public: 00888867224117
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101679
• 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): 04/30/2024

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: 03/31/2023
• Device Model Number: 2.9MM BIOCOMPOSITE PUSHLOCK KIT
• Device Catalogue Number: AR-2923BC-K
• Device Lot Number: 13575552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown