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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 4th september 2024, it was reported by an arthrex employee via email that an ar-1922bc, suture anchor, biocomposite pushlock® 4.5 x 24 mm, the anchor broke during insertion.This was detected during use in a rotator cuff repair surgery on (b)(6) 2024.All the fragments have been retrieved from patient.The procedure was completed successfully by using a new ar-1922bc.There was no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1922bc serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to the damage to the device.Visual inspection noted that the eyelet of the device is bent.The most likely cause is attributed to misuse due to prying/leveraging the device during use.Per dfu-0087 section e.Warnings.6: " bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.Section g.Precautions.3.Make sure to use the recommended drill bit or punch to create the bone socket.4.Pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.5.Pushlock and swivelock suture anchors only: insert the driver into the bone socket until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during final advancement of the anchor body.6.Pushlock and swivelock suture anchors only: ensure that the anchor body is in full contact with the bone before advancing the anchor body into the prepared bone socket."l5.

• 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: 20236915
• Report Number: 1220246-2024-07672
• Device Sequence Number: 12773329
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 15194023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2024
• 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