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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that after procedure, where regeneten bioinductive implant was used, the patient had pain and irritation on (b)(6) 2021.On a second surgery, it was noticed that the device become dislodged and was not secured to the supraspinatus tendon.It had bunched up and was partially attached to the acromion.The implant, bone anchors and tendon anchors were removed.The patient outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).B5 and d4: updated.
Event or Problem Description
It was reported that on (b)(6) 2021 patient had a left shoulder arthroscopic rotator cuff repair using a regeneten patch.After this the patient presented pain and had to be treated with medication, injections and phyisical therapy.On (b)(6) 2021 the patient had a revision surgery where there was evidence of a midsubstance rupture of the bio inductive patch with tissue flipped on itself in the lateral glutter and also a ridge on the acromion which may have corresponded to the contact of the graft.The rupture of the patch was debrided with a combination of a shaver and grasper from the lateral portal, the 2 bone staples were removed and the soft tissue staples were also removed with a combination of a grasper and a shaver.The ridge was smoothed with a shaver.After this procedure patient presented pain again, medications were also provided.Current status of the patient is unknown.
Additional Manufacturer Narrative
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 specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was 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 based on the information provided, the definitive clinical root cause of the reported adverse event could not be determined.However, we cannot rule out the patient¿s non-compliance with the rehabilitation plan as a potential contributory factor to the reported events.Approximately seven-months post procedure this patient reports she is doing her home exercises and feels like she is improving.The patient rates her pain as 2 on a scale of 10, and she is happy with her progress.Therefore, the patient impact beyond what was reported could not be determined.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.Based on this investigation, the need for corrective action is not indicated.If the product associated.

• 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: 12445090
• Report Number: 3003604053-2021-00246
• Device Sequence Number: 3516923
• Product Code: OWY
• UDI-Device Identifier: 00885556735657
• UDI-Public: 885556735657
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K140300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

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: 12/10/2023
• Device Catalogue Number: 4565
• Device Lot Number: A8686
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 01/24/2022; 07/16/2024
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 02/06/2022; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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