MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR S 2 UB STR BLUE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72203852

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 08/10/2020

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2020, the patient had a bankart repair and capsular stabilization surgery where a "1.7mm suturefix ultra anchor was implanted to him.However, after this surgery, the patient had recurrent instability and on (b)(6) 2020 began experiencing a recurrent left shoulder dislocation on trivial injury.As a result, the patient went under a revision surgery (open laterjet procedure) on (b)(6) 2020 for shoulder repair and is currently recovering.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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.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 concluded this was an isolated event.A review of risk management files found that the reported failure effect was documented appropriately.The suturefix ultra suture anchor 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.The images provided of the initial repair show the anchors appear secure.Based on the information provided the root cause of the reported events could not be concluded if related to the anchors holding, quality of soft tissue, or insufficient initial stabilization.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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: SUTUREFIX ULTRA AHR S 2 UB STR BLUE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10819745
• MDR Text Key: 215618755
• Report Number: 1219602-2020-01818
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554030037
• UDI-Public: 00885554030037
• Combination Product (y/n): N
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203852
• Device Catalogue Number: 72203852
• Device Lot Number: 2036308
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 78