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

Model Number SUTR ANCH,BIO-COMP S-TAK

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2024

Event Type  malfunction  

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 Description

On 03/26/2024, it was reported by an arthrex subsidiary employee via email that an ar-1934bcf-2 biocomposite suturetak anchor broke inside the patient.All the broken fragments were removed, and the case was completed using a new ar-1934bcf-2 biocomposite suturetak.This was discovered during an ankle ligament repair procedure on (b)(6) 2024.Additional information received 3/29/2024: the case was delayed fifteen minutes; however, additional anesthesia was unnecessary.

• Brand Name: SUTR ANCH,BIO-COMP S-TAK
• Type of Device: 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: 19154280
• MDR Text Key: 340731308
• Report Number: 1220246-2024-02212
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867023888
• UDI-Public: 00888867023888
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Model Number: SUTR ANCH,BIO-COMP S-TAK
• Device Catalogue Number: AR-1934BCF-2
• Device Lot Number: 15014658
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1