MAUDE Adverse Event Report: ARTHREX, INC. 2.9MM BIOCOMP PUSHLOCK, DX; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	2.9MM BIOCOMP PUSHLOCK, DX
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
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 an arthrex employee via email that an ar-8923bc biocomposite pushlock eyelet broke off when an ar-7500 suturetape was passed through the eyelet and inserted.A new product was used and case was completed without further issues.This was discovered during a procedure on (b)(6) 2022.
Additional Manufacturer Narrative
Upon visual inspection, no problem was noted with the inserter.As the screw and anchor were not returned for investigation, the complaint cannot be confirmed.

• Brand Name: 2.9MM BIOCOMP PUSHLOCK, DX
• 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: 15093386
• Report Number: 1220246-2022-05283
• Device Sequence Number: 5161301
• Product Code: MAI
• UDI-Device Identifier: 00888867131491
• UDI-Public: 00888867131491
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 01/31/2024
• Device Model Number: 2.9MM BIOCOMP PUSHLOCK, DX
• Device Catalogue Number: AR-8923BC
• Device Lot Number: 14930818
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown