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

Catalog Number	4565
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that after an arthroscopy, using a regeneten implant, the patient's tissue healed.However, not all parts of the implant stayed intact.On (b)(6) 2023, a revision rotator cuff repair surgery was performed to remove the loose body regeneten implant from the patient's shoulder.The procedure was completed without surgical delay.No further complications were reported.The patient outcome is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H2: additional information in d1 (brand name), d4(catalog no, lot no, exp.Date), and h4(mfg.Date).
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).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 packaging assembly found that parts should be packaged in such a way to prevent damage.A clinical review states that based on the information provided no clinical factors were found which would have contributed to the reported events.The regeneten bioinductive implant is implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.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.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.H11: corrected information in h6 (health effect - impact code).

• Brand Name: BIOINDUCTIVE IMPLANT W/ARTH DEL MED
• 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: 17750023
• Report Number: 3003604053-2023-00038
• Device Sequence Number: 7192639
• Product Code: OWY
• UDI-Device Identifier: 00885556735657
• UDI-Public: 885556735657
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2025
• Device Catalogue Number: 4565
• Device Lot Number: 2085850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 09/14/2023; 02/16/2024
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 09/19/2023; 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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: Unknown