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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, approximately, a month and half after an arthroscopy where a regeneten bioinductive implant was used, a raised sack appeared on the intra lateral portal of the patient.Synovial fluid was draining out of the sack with some chunks.When the sack was decompressed and then abducted, particles could be seen.It is unknown how the injury was treated or the patient's outcome.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 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 clinical review states that three undated photos of the ¿raised sack¿ were provided for review and confirm the reported.Based on the limited information provided no clinical factors were found which would have contributed to the reported event.While it was reported that the fluid was drained from the patient, it is unknow if the reported ¿particles¿ were removed from the patient.The regeneten bioinductive implant, bone anchors, and tendon anchors are implantable; thus, biocompatibility is not an issue.If retained, micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.The root cause of the reported event could not be determined due to the limited clinical information provided.Based on the limited information provided we are unable to conclude on factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.H11: corrected information in h6 (health effect - clinical & impact code).

• 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: 16950213
• Report Number: 3003604053-2023-00022
• Device Sequence Number: 3340136
• Product Code: OWY
• UDI-Device Identifier: 00885556735664
• UDI-Public: 885556735664
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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: 11/04/2024
• Device Catalogue Number: 4566
• Device Lot Number: 2082935
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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: Other
• Patient Sex: Male