MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 01/22/2024

Event Type  malfunction  

Event Description

On 2/13/2024, it was reported by a facility representative via email that an ar-1320bcnf suture anchor pulled out.No additional information provided.Additional information requested.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
• Type of Device: 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: 18810053
• MDR Text Key: 336584586
• Report Number: 1220246-2024-01223
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/29/2024

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 MICROBIO-COMP S-TAK 2.4X 6.5MM
• Device Catalogue Number: AR-1320BCNF
• Device Lot Number: 12547988
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2021
• 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