MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHRO BIOINDCTIVE 1 MED; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number 2169-2

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 06/09/2020

Event Type  Injury  

Event Description

It was reported that the patient presented to 1 year visit on with repeat mri and complained of shoulder pain.Upon review of mri, it was noted she has a moderate grade partial thickness rotator tendon tear.Initially, the patient did not want to proceed with surgical intervention but, she reached out to the pi to schedule surgery.The patient was treated with therapy and revision surgery however the event is still on going.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.A review of the instructions for use found the need for repeated surgery because tendons do not heal properly or tear again.A review of risk management files found that the reported failure was documented appropriately.Clinical evaluation found that no further medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: ARTHRO BIOINDCTIVE 1 MED
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10262194
• MDR Text Key: 198504961
• Report Number: 3003604053-2020-00064
• Device Sequence Number: 1
• Product Code: OWY
• UDI-Device Identifier: 00854501006005
• UDI-Public: 854501006005
• Combination Product (y/n): N
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2169-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 76