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

Model Number	72203842
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during a hip labrum suture surgery procedure, two suturefix ultra ahr xl 2 ub blue/wh broke during the implantation since the mechanism did not allow the anchors to be released.Procedure finished with two suturefix backup implants with no delay.The patient will be hospitalized again because there is a residual foreign body in her hip.
Additional 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 the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.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 review of risk management files found that the reported failure was documented appropriately.A review of the material found there are requirements for conformance and a certificate of material analysis is required.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 investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H3, h6: part of the reported device was received for evaluation.A visual inspection found the device was returned without the suturefix anchor or suture and the button and trigger were actuated.The inserter tip fork was hidden within the shaft since the device had been actuated.A functional evaluation could not be performed as the device had already been actuated.Based on the condition of the product material found during visual inspection, additional material testing is not required.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 no 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 review of the suture material specifications found a material certificate of analysis is required.A clinical review states if a portion of the anchor remains retained in the patient, it is made of a biocomposite material which is intended for implantation to allow for bone growth.The root cause could not be determined as the anchor/suture was not returned for analysis.Factors that may have contributed to the reported event include unintended excessive force on insertion or off-axial insertion.No containment or corrective actions are recommended at this time.

• Brand Name: SUTUREFIX ULTRA AHR XL 2 UB BLUE/WH
• Common Device Name: 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: 12015851
• Report Number: 1219602-2021-01381
• Device Sequence Number: 14507971
• Product Code: MBI
• UDI-Device Identifier: 00885554031553
• UDI-Public: 00885554031553
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2025
• Device Model Number: 72203842
• Device Catalogue Number: 72203842
• Device Lot Number: 2041448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/14/2021; 11/22/2023
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/30/2021; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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: Required Intervention
• Patient Sex: Unknown