MAUDE Adverse Event Report: ARTHREX INC. SUTURE ANCHOR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number AR-1927BCF-3

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/13/2023

Event Type  malfunction  

Event Description

Suture anchor broke into two pieces.One piece retrieved from patient.One piece of absorbable suture anchor remains in patient bone per physician.Patient remains stable at this time.

• Brand Name: SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.
• MDR Report Key: 17186191
• MDR Text Key: 317876303
• Report Number: MW5118707
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-1927BCF-3
• Device Lot Number: 14954089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Race: White