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

Model Number 72203853

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Information (3190); Unspecified Tissue Injury (4559)

Event Date 08/26/2020

Event Type  Injury  

Event Description

It was reported that during a procedure the anchor of the suturefix pulled out, another bone hole was performed to complete the procedure with a backup device.There was no delay or further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was returned with original packaging.The anchor is missing, and the device appeared to have been actuated due to the placement of dl trigger.Further review found device was not actuated all the way due to trigger was not snapped back and locked in place.No physical damage visible to the device.A functional evaluation of the returned device found that device did work due to the trigger of device sliding back and locking into place during assessment.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.A complaint history review concluded this was a repeat issue.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.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.

Event Description

It was reported that during a procedure the suturefix anchor pulled out, another bone hole was performed to complete the procedure with a backup device in an additional bone hole.There was no surgical delay or further complications reported.

• Brand Name: SUTUREFIX ULTRA AHR S 2 UB STR CB BLU
• 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: 10564080
• MDR Text Key: 207885380
• Report Number: 1219602-2020-01443
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554031447
• UDI-Public: 00885554031447
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 04/07/2022

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 Model Number: 72203853
• Device Catalogue Number: 72203853
• Device Lot Number: 2049962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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): Required Intervention