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

Model Number	4566
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577)
Date of Event	11/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after approximately four months of an achilles repair procedure with regeneten, a patient had severe pain and swelling of the achilles area.A ct showed an abscess within the achilles tendon so an incision was made to debride the area.The cultures showed a mssa infection.The patient was treated and the infection was resolved.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
A device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was 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 clinical review states that the reported swelling, pain, necrotic tissue, mssa, esr 21, and the ct report that revealed an abscess within the achille¿s tendon were all consistent with the reported post-surgical infection.However, based on the information provided the definitive source of the reported infection could not be determined, although, user technique/non-compliance as potential contributory factors could not be ruled out.It cannot be concluded that the reported abscess is a malfunction of the regeneten implant vs a complication of the surgical procedure.Reportedly, the patient was last seen on (b)(6), still on boot therapy without signs of infection.According to the report, the patient was a no show for his last scheduled follow-up appointment.However, it was reported that the infection was resolved after treatment was provided.Based on the limited information provided a thorough medical assessment could not be performed; therefore, we are unable to conclude specific factors known to contribute to the alleged report.Based on this investigation, the need for corrective action is not indicated.H11: h2: corrected information: 510k, d1, d2, d4, h4 and h6: health effect - impact code.
Additional Manufacturer Narrative
H11: h2: corrected information: d4: unique identifier (udi) #.

• 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: 13529302
• Report Number: 3003604053-2022-00006
• Device Sequence Number: 14471545
• Product Code: OWY
• UDI-Device Identifier: 00885556735664
• UDI-Public: 00885556735664
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2023
• Device Model Number: 4566
• Device Catalogue Number: UNKNOWN
• Device Lot Number: A8692
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 07/18/2024; 08/05/2024
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 07/24/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male