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

Catalog Number	72203853
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, after the sututerfix ultra was placed bone hole; when the anchor was being tied, it came out from the glenoid.The procedure was completed with non-significant surgical delay using a smith and nephew back up device in an additional drilled bone hole.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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 clinical review states that the photos of the device and packaging box was provided for review however the photos do not indicated a clinical root cause for the reported event.Based on the limited information provided the clinical root cause of the reported events cannot be determined and 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.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: 17724156
• Report Number: 1219602-2023-01728
• Device Sequence Number: 7005022
• Product Code: MBI
• UDI-Device Identifier: 00885554031447
• UDI-Public: 885554031447
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/29/2023

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 Catalogue Number: 72203853
• Device Lot Number: 2101938
• 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: 08/19/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2022
• 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: Other
• Patient Sex: Unknown