MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/05/2024, it was reported by an arthrex subsidiary employee via email that an ar-1922bc suture anchor broke during insertion.All fragments were retrieved from the patient.The case was completed using another new ar-1922bc suture anchor with no secondary procedure needed.This was discovered during a rotator cuff repair surgery on (b)(6) 2024.
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.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual evaluation, it was determined that the bio-pushlock was broken, and the eyelet was warped.Functional testing was not performed due to the damage to the implants.The method used to prepare the bone, as well as the bone quality encountered, was provided.The most likely cause of the reported failure can be attributed to user error due to misaligned insertion or improper leveraging of the device during the insertion process.

• Brand Name: SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK
• 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: 18776554
• Report Number: 1220246-2024-01112
• Device Sequence Number: 11890326
• Product Code: MAI
• UDI-Device Identifier: 00888867022874
• UDI-Public: 00888867022874
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082810
• 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): 09/03/2024

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, BIOCOMPO- SITE PUSHLOCK
• Device Catalogue Number: AR-1922BC
• Device Lot Number: 15092913
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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