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

Catalog Number UNKNOWN

Device Problem Degraded (1153)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/18/2019

Event Type  Injury  

Event Description

It was reported that after a rotator cuff repair on a tear where a bioinductive patch was used, the patient never healed from this procedure and experienced a continuing pain.Therefore, a revision surgery was required to treat this pain, where it was found that the bioinductive patch had defragmented in the patients shoulder.All pieces were removed from the patient and no new patch was used.Current status of the patient is numb from middle of right side chest down right shoulder/ arm to right 3 fingers (thumb, pointer, and middle) continuous pain in right shoulder rotor cuff, right side neck, and right bicep.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, h3, h6: 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 a repeat issue.Instructions for use and product labels were not reviewed due to unavailability of device information.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: REGENETEN BIOINDUCTIVE IMPLANT SYSTEM
• 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: 10271448
• MDR Text Key: 198733220
• Report Number: 3003604053-2020-00067
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention