MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-S-TAK,SM JNT; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,BIO-S-TAK,SM JNT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/14/2024, it was reported by an arthrex subsidiary employee via e-mail that an ar-8934bnf small joint bio-suturetak® with needles fiber was broken.This was discovered outside the patient during a meniscus repair 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
Additional information: g3, h3, h6.The complaint allegation is not confirmed.Based on the image provided from the field, the device and packaging do not match the complaint allegation.Consequently, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misaligned insertion, prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH,BIO-S-TAK,SM JNT
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 19023426
• Report Number: 1220246-2024-01786
• Device Sequence Number: 12800971
• Product Code: HWC
• UDI-Device Identifier: 00888867050372
• UDI-Public: 00888867050372
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050749
• 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): 05/22/2025

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 Expiration Date: 05/31/2026
• Device Model Number: SUTR ANCH,BIO-S-TAK,SM JNT
• Device Catalogue Number: AR-8934BNF
• Device Lot Number: 14966868
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2022
• 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