MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENDON ANCHORS 8; STAPLE, IMPLANTABLE

Catalog Number	2504-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Synovitis (2094)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a regeneten implantation procedure using the tendon anchors in 2022, the patient had rice bodies and experienced pain, a washout was performed on (b)(6) 2023.The current patient status improved since washout.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10 h6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.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 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 clinical review states that all documents and images provided have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.It should be noted the patient has a depuy/synthes peek anchor implanted.The reported pain and swelling may be consistent with the reported rice bodies; however, the clinical root cause of the rice bodies cannot be confirmed.It cannot be concluded the rice bodies were associated with the s&n implants.The patient impact beyond the reported events cannot be determined; however, it is noted the patient status has improved.No further clinical assessment is warranted at this time.Based on the limited information provided we are unable to conclude on factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined with the clinical information provided.A review of device and sterilization 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 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 clinical review states that the implantation operative report noted, significant synovitis and a shaver was used to remove fibrous tissue from the acromial undersurface.It was reported, nine-months post implantation patient had pain and swelling, and mri demonstrated subacromial swelling with innumerable rice bodies.Patient had a debridement and washout.The operative report indicated, innumerable rice bodies in subacromial space likely well over 100.The mir and arthroscopic images were provided which support the report but do not indicate a root cause.Inflamed subacromial space with friable tissue underlying acromion and overlying rotator cuff.It is reported patient status improved since washout.The provided photos were reviewed and demonstrate what was reported as ¿rice bodies¿.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.As conclusion, it should be noted that the patient has a depuy/synthes peek anchor implanted.The reported pain and swelling may be consistent with the reported rice bodies; however, the clinical root cause of the rice bodies cannot be confirmed.It cannot be concluded the rice bodies were associated with the s&n implants.The patient impact beyond the reported events cannot be determined; however, it is noted the patient status has improved.No further clinical assessment is warranted at this time.Based on the information provided, we are unable to conclude specific factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.Corrected data: h6: health effect - clinical and impact code.

• Brand Name: TENDON ANCHORS 8
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 18048674
• Report Number: 3003604053-2023-00068
• Device Sequence Number: 7468734
• Product Code: GDW
• UDI-Device Identifier: 00854501006067
• UDI-Public: 00854501006067
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2025
• Device Catalogue Number: 2504-1
• Device Lot Number: 51009391
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 12/22/2023; 03/15/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 01/04/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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: Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male