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

Model Number	SUTURE ANCHOR, MINI BIO-PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex's employee via email that for an ar-8825b, suture anchor, mini bio-pushlock¿ 2.5 mm x 8 mm, when the surgeon inserted the anchor, the screw broke off easily and the eyelet fell out easily.This was detected during a tfcc repair on (b)(6) 2025.The case was completed successfully by using another ar-8825b.There was no patient harm.Additional information: there was a delay of about 10 minutes.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Due to the device not being returned and no photos of the reported failure being provided, the complaint allegation cannot be confirmed.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.The dfu for this device, dfu-0087-eo revision 4, gives the following warnings and precautions: -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.-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.-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.

• Brand Name: SUTURE ANCHOR, MINI BIO-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: 22690000
• Report Number: 1220246-2025-03212
• Device Sequence Number: 9045289
• Product Code: MAI
• UDI-Device Identifier: 00888867046641
• UDI-Public: (01)00888867046641(11)241023(17)280930(10)15336512
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K173240
• 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): 10/14/2025

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, MINI BIO-PUSHLOCK
• Device Catalogue Number: AR-8825B
• Device Lot Number: 15336512
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown