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 Codes	Break (1069); Material Deformation (2976)
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 (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: the reported device was received for evaluation.It was determined the device contributed to the reported event.A visual inspection found the distal tip of the device was damaged and bent, the suture was pulled into the inserter shaft, the trigger and button had been actuated, and the suture stuck in the end of the inserter was frayed.A functional evaluation could not be performed as the device was already actuated.Additional material testing cannot be performed since the broken implant was not returned.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 found no similar reported events.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.A review of the suture raw material sheet found a material certificate of analysis is required.A clinical review states that the instructions for use does caution that: use of excessive force during insertion can cause failure of the suture anchor or insertion device.Bone quality must be adequate to allow proper placement of the suture anchor.Do not alter the implant or instrumentation, otherwise performance may be compromised.Once seated, do not rotate the suture anchor device in the bone as this may cause device failure.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.If the implant was retained, it is unknown if the suture anchor will migrate and there is potential risk for tissue inflammation and/or pain.The complaint was confirmed and the root cause associated with an unintended use of the device.Factors that may have contributed to the reported event include unintended excessive force upon insertion or contact to the distal tip of the inserter with another source.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: 12015852
• Report Number: 1219602-2021-01382
• Device Sequence Number: 4219483
• 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): 01/17/2024

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: 04/25/2024
• Device Model Number: 72203842
• Device Catalogue Number: 72203842
• Device Lot Number: 2032827
• 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; 01/15/2024
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/30/2021; 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2019
• 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