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	Inflammation (1932)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the patient presented an inflammation 6 weeks after a surgery where 2 regeneten devices were used.The patient was brought back to surgery at 8 weeks, no infection was found but the doctor felt the regeneten was ¿mushy¿ and decided to remove it.He was not sure if there was an issue with regeneten, but he is also not sure it was incorporating like it should.Fixation could have also been an issue as the distal part of the implant may not have been fixated well.No additional complications were reported.
Additional Manufacturer Narrative
Correction in d2 and g4 (510k).
Additional Manufacturer Narrative
H10: h2: additional information on b5.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 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.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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that the patient presented an inflammation 6 weeks after a surgery where a regeneten implant was used.The patient was brought back to surgery at 8 weeks, no infection was found but the doctor felt the regeneten was ¿mushy¿ and decided to remove it.He was not sure if there was an issue with regeneten, but he is also not sure it was incorporating like it should.Fixation could have also been an issue as the distal part of the implant may not have been fixated well.No additional complications were reported.

• 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
• 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: 15591584
• Report Number: 3003604053-2022-00056
• Device Sequence Number: 2136079
• Product Code: ORQ
• UDI-Device Identifier: 00885556735664
• UDI-Public: 885556735664
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K140300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2023
• 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: 01/20/2025
• Device Catalogue Number: 4566
• Device Lot Number: 2087383
• 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: 09/22/2022
• Supplement Date Received by Manufacturer: 05/17/2023; 06/05/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 05/18/2023; 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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: Unknown