MAUDE Adverse Event Report: ARTHREX, INC. 3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
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 3/18/2024, it was reported by a sales representative via email that an ar-1926bcsp biocomposite pushlock anchor eyelet broke on impaction.The broken fragments were removed from inside the patient.This was discovered during an rcr procedure on (b)(6)2024.Additional information received on 3/26/2024: there was no delay in the procedure, and additional anesthesia was not needed.The patient suffered no negative effects.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual evaluation of the attached picture revealed that the eyelet implant had fractured at the junction between the base of the eyelet and the threaded tip of the shaft, which is the point of connection to the driver.Functional testing was not performed due to the device's damage.Bone quality and bone preparation were provided.The most likely causes of reported failure are misaligned insertion or prying/leveraging the device during insertion.

• Brand Name: 3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING
• 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: 19067350
• Report Number: 1220246-2024-01895
• Device Sequence Number: 17790436
• Product Code: MAI
• UDI-Device Identifier: 00888867395213
• UDI-Public: 00888867395213
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K221099
• 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): 07/23/2024

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: 3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING
• Device Catalogue Number: AR-1926BCSP
• Device Lot Number: 15191501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2024
• 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