MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W/ARTH DEL LRG; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number	4566
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Inflammation (1932); Fluid Discharge (2686)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that the regeneten bioinductive implant "scaffold" was used on a patella tendon revision.The implant was sutured on the top of the repair and no staples were used.Three months after the operation, a wash out was preformed because the patient developed a recalcitrant pre-patellar bursitis.The doctor aspirated many times and a milky fluid came out.The cultures were negative.The doctor believes that the inflammatory reaction happened due to the scaffold breaking down.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H2: updated data on h6 (clinical code and impact code).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined.Since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were reviewed and 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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the device specifications found all dimensions or notes w/ circular number annotations will be inspected at incoming inspection.A clinical review states that the impact to the patient beyond that which has already been reported is unknown.Should any additional medical information be provided, this complaint will be re-assessed.Therefore, no further clinical/medical assessment is warranted at this time.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: BIOINDUCTIVE IMPLANT W/ARTH DEL LRG
• Common Device Name: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11478734
• Report Number: 3003604053-2021-00086
• Device Sequence Number: 3877254
• Product Code: OWY
• UDI-Device Identifier: 00885556735664
• UDI-Public: 885556735664
• Combination Product (Y/N): N
• PMA/510(K) Number: K140300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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 Expiration Date: 08/18/2023
• Device Catalogue Number: 4566
• Device Lot Number: A8559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown