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

Catalog Number UNKNOWN

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

Patient Problems Failure of Implant (1924); Scar Tissue (2060); Muscle/Tendon Damage (4532)

Event Date 11/22/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2020 a left shoulder rotator cuff repair, distal clavicle excision, extensive debridement, biceps tenodesis, and subacromial decompression were performed, where healicoil and multifix smith & nephew suture anchors and regeneten implants were placed.On (b)(6) 2022, the patient felt a pop when doing therapy and developed severe pain and noticed that his bicep had sunken into his arm.On (b)(6) a revision surgery was performed and it was discovered that the smith & nephew anchor(s) failed, which caused a high-grade cuff tear among other serious complications.Surgeon removed the failed hardware and placed two q-fix implants.An extensive debridement of the scar tissue where he had stiffness was made.The central aspect of the medial row anchor had pulled out and a broken cuff anchor had to be removed, as well as the loose anchor debris.Then, an additional lateral row anchor for additional footprint coverage and stability was placed.The current status of the patient is unknown.

Manufacturer Narrative

H10: internal complaint reference: case: (b)(4).

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.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 that the patient has a history of extensive shoulder injury including, left shoulder rotator cuff tear, subacromial impingement, distal clavicle arthrosis, biceps tendon subluxation out of its groove, and labral fraying.The provided images were reviewed but are of poor quality and do not aid in the investigation.The reported, stiff shoulder may be consistent with the intraoperative finding of scar tissue.Scar tissue is a known complication of surgery and is associated with the surgical procedures.With the information provided the clinical root cause of the reported biceps tenodesis rupture, and high-grade partial tear cannot be definitively concluded; however, the revision report notes portion of the medial aspect of the cuff had not healed, the patients¿ prior history of extensive shoulder injury and/or weight bearing and body stresses on the appliance, prior to healing of the medial aspect of the cuff, cannot be ruled out as possible contributing factors.The patient impact beyond the reported events cannot be determined.No further clinical assessment is warranted at this time.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.Correction in a1 (should be read in blank) and h6 (health effect - clinical code).

• Brand Name: UNKNOWN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM INSTR
• 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: 17102384
• MDR Text Key: 316946509
• Report Number: 3003604053-2023-00026
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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