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

Model Number	2.9MM BIOCOMP PUSHLOCK, DX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
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) 2023, it was reported by an arthrex employee via email that an ar-8923bc biocomposite pushlock shaft broke while inserting the anchor.All broken pieces were removed from inside the patient.Case was completed using another ar-8923bc biocomposite pushlock.This was discovered during an atfl repair on (b)(6) 2023.
Additional Manufacturer Narrative
Complaint is confirmed.Visual evaluation noted that the returned device was broken at the welding area of the base of the shaft.The broken metal pieces or implants were not returned for investigation.The most probable cause of this condition is that the base was hit at the wrong angle and caused the welding area to break.Most likely cause is attributed to misuse due to user error.

• Brand Name: 2.9MM BIOCOMP PUSHLOCK, DX
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16847807
• Report Number: 1220246-2023-06652
• Device Sequence Number: 17773850
• 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): 08/16/2023

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: 11/30/2024
• Device Model Number: 2.9MM BIOCOMP PUSHLOCK, DX
• Device Catalogue Number: AR-8923BC
• Device Lot Number: 15032794
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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