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 No Information (3190)

Event Date 09/29/2020

Event Type  Injury  

Event Description

It was reported that during a shoulder arthroscopy, the anchor of ultrabraid suture detached from the incision site, therefore, it has to be removed.The procedure was successfully completed without delay using a q-fix.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device was received for evaluation.A visual inspection revealed the device was returned outside of original packaging.The release mechanism has been actuated.The anchor and suture have been returned and is discolored with debris.No physical damage visible.A functional evaluation of the returned device found that device has been actuated therefore no function test can 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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate there was no way to determine if the device contributed to the reported event.Per complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.Based on the information provided, both anchors were removed after the detachment of two failed implantation of the ultra braid anchor.According to the report, the procedure was successfully completed without delay using a q-fix.Since no other complications were reported, no further clinical/medical assessment is warranted at this time.The complaint was not confirmed, and the root cause could not be determined as the condition in which the device was received did not allow for evaluation of the reported complaint.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the 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.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10723745
• MDR Text Key: 212675811
• Report Number: 1219602-2020-01641
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554030037
• UDI-Public: 00885554030037
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2023
• Device Model Number: 72203852
• Device Catalogue Number: 72203852
• Device Lot Number: 50707680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 05/19/2022
• Supplement Dates FDA Received: 10/28/2020; 05/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention