MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM DEV; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 06/16/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that after a shoulder surgery on (b)(6) 2022, using the regeneten device, the patient experienced a rotator cuff re-tear on (b)(6) 2022.A revision surgery was completed on (b)(6) 2022 in which subscapularis repair, loose body removal, revision massive supraspinatus and infraspinatus repair was performed.The regeneten patch from original procedure were successfully removed to treat the patient reported condition.A new regeneten device was used.The status of the patient is ongoing.

Manufacturer Narrative

H10: 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.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.Insufficient product identification information was provided and thus a complaint history review could not be conducted.Insufficient product identification information was provided, and thus, an instruction for use review could not be conducted.Insufficient product identification information was provided and thus a risk management review could not be conducted.A clinical review states per case details, a study patient reportedly experienced a ¿right deltoid muscle strain progressed to rotator cuff re-tear.¿ as of the date of this medical investigation, the requested clinical documentation (including the surgical report) has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The crfs were reviewed, but do not provide insight into the cause of the reported event.The patient impact beyond the reported is not anticipated as it has been communicated, the ¿loose body and the ¿original¿ regeneten patch were removed during the revision (including repair of the subscapularis, supraspinatus, and infraspinatus muscles).The patient outcome is reportedly ¿resolved.¿ therefore, no further clinical/medical assessment can be rendered.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.

• Brand Name: UNKNOWN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM DEV
• Type of Device: 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: 16396707
• MDR Text Key: 309753484
• Report Number: 3003604053-2023-00004
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 118 KG