MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W/ARTH DEL LRG; MESH, SURGICAL, DEPLOYER

Catalog Number	4566
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the patient had rotator cuff repair 7 weeks ago and was augmented with regeneten bioinductive implant.The patient started experiencing irritation and inflammation.Surgeon scoped the shoulder and found a fully intact bioinductive implant as well as white risotto like substance.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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.Insufficient 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.An analysis of the customer provided image found a used implant.A review of the instructions for use found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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: BIOINDUCTIVE IMPLANT W/ARTH DEL LRG
• Common Device Name: MESH, SURGICAL, DEPLOYER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11135550
• Report Number: 3003604053-2021-00006
• Device Sequence Number: 846889
• Product Code: ORQ
• UDI-Device Identifier: 00885556735664
• UDI-Public: 885556735664
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 4566
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1