MAUDE Adverse Event Report: SMITH & NEPHEW INC. BIOINDUCTIVE IMPLANT WITH ARTHRO; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Model Number 4566

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/25/2024

Event Type  Injury  

Event Description

The graft inserter- the piece that holds the graft in place, broke off in the joint space in the patient's lateral gutter (shoulder).Had to use a grasper to rip it out of the joint.

• Brand Name: BIOINDUCTIVE IMPLANT WITH ARTHRO
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): SMITH & NEPHEW INC.
• MDR Report Key: 18622748
• MDR Text Key: 334444013
• Report Number: MW5150952
• Device Sequence Number: 1
• Product Code: OWY
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4566
• Device Lot Number: 2123446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 100 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White