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

Model Number	72203853
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a latarjet stop under arthroscopy with bankart, the suturefix anchor did not hold and broke during installation.The procedure was completed with one of the faulty devices that was positioned without problem, the bead was repaired with 1 anchor instead of 2.The rest of the broken pieces were removed from the patient by pulling on the strands, since the failure was a defect in the fixation of the anchor during its release.There was a 30-minute surgical delay reported.No void was left in the patient.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 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 material specifications found that a material certificate of analysis is required.A clinical review states that this case reports the breakage of the three suturefix anchors and while it was communicated that the broken pieces were removed from the patient, it was also noted that ¿the procedure was completed with one of the faulty devices.¿ no clinically relevant supporting documentation was provided for inclusion in a medical investigation.Based on the information provided no clinical factors were found which would have contributed to the reported breakage.The suturefix anchor is implantable, biocompatibility is not an issue.The size of the ¿faulty¿ anchor is unknown.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.It was communicated via e-mail that, ¿the patient is doing very well, the technical problem will not affect the final result.¿ no further clinical/medical assessment is warranted at this time.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.

• Brand Name: SUTUREFIX ULTRA AHR S 2 UB STR CB BLU
• 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: 16516949
• Report Number: 1219602-2023-00346
• Device Sequence Number: 3290400
• Product Code: MBI
• UDI-Device Identifier: 00885554031447
• UDI-Public: 00885554031447
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2023

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 Model Number: 72203853
• Device Catalogue Number: 72203853
• Device Lot Number: 2105960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2022
• 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 Age: 17 YR
• Patient Sex: Male
• Patient Weight: 75 KG