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

Catalog Number 4565

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  Injury  

Event Description

It was reported that after an arthroscopy procedure with a bioinductive implant on (b)(6), a patient went in for revision debridement surgery on (b)(6) due to subacromial space turning to bone.No further complications were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

H10: b5, e1 (contact name), e2 and e3.

Event Description

It was reported that after an arthroscopy procedure with a bioinductive implant on (b)(6) 2021, a patient went in for revision debridement surgery on (b)(6) 2021 due to subacromial space turning to bone.No further complications were reported.The current status of the patient is fine.

Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 review of risk management files found that the reported failure was not covered in the risk documentation.The risk file is being updated to include the reported failure mode.This case reports that five months following the implantation of a bioinductive implant a revision surgery was performed due to ¿subacromial space turning to bone.¿ preoperative x-rays and prerevision x-ray demonstrating radio-dense area on the lateral aspect of the humeral head consistent with the regeneten.Also provided for review, one intraoperative photo and one photo of the removed fragments of what was removed.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the limited information provided, the clinical root cause of the reported events could not be determined.The observations noted were taken as reported but no pathology of the removed particles is available.The impact to the patient beyond the reported revision cannot be concluded.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include a biological response to the procedure or device.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: BIOINDUCTIVE IMPLANT W/ARTH DEL MED
• 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: 14911643
• MDR Text Key: 295234346
• Report Number: 3003604053-2022-00023
• Device Sequence Number: 1
• Product Code: OWY
• UDI-Device Identifier: 00885556735657
• UDI-Public: 885556735657
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2023
• Device Catalogue Number: 4565
• Device Lot Number: A8417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• 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): Other