MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENDON ANCHORS 8; MESH, SURGICAL, COLLAGEN, ORTH, RNFRCMNT OF TENDON

Model Number 2504

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

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that a patient had a surgery on october 9 where tendon anchors were used.3.5 weeks later they presented in the office with an infection.Wash out was done october 29th by a different surgeon.One staple was proud and alleged he was causing the bursa to become inflamed.Patient was put on two weeks of iv antibiotics.After three days of steroids it seems to be improving and the surgeon thinks it¿s an allergic reaction to the staples.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that a patient had a surgery on (b)(6) where tendon anchors were used.3.5 weeks later they presented in the office with an infection.Wash out was done (b)(6) by a different surgeon.One staple was proud and alleged he was causing the bursa to become inflamed.Patient was put on two weeks of iv antibiotics.After three days of steroids it seemed to be improving and the surgeon thought it was an allergic reaction to the staples.Later on, it was found that after the second debridement with negative cultures, the patient had psoriasis from a biopsy performed earlier in 2020.The patient was supposed to begin biological medication to treat psoriasis but she did not, which caused the serious drainage without any bacterial growth.This was not related to the implant or any issue with the device.The patient also rupture her initial repair.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional information.

Manufacturer Narrative

Internal complaint reference (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.A review of the instructions for use found fever and/or infection and tissue inflammation as a risk and side effect.A review of risk management files found that the reported failure was documented appropriately.Clinical evaluation found that no further medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: TENDON ANCHORS 8
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTH, RNFRCMNT OF TENDON
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11028582
• MDR Text Key: 222071690
• Report Number: 3003604053-2020-00170
• Device Sequence Number: 1
• Product Code: OWY
• UDI-Device Identifier: 00854501006067
• UDI-Public: 00854501006067
• Combination Product (y/n): N
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2504
• Device Catalogue Number: 2504-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention