MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX CRV AHR S 2 #1 UB STR BL BL-CB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72204689
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the suturefix insertion device was missing the button and trigger from the handle, and the nose tube and suture cover were damaged; the entire distal end of the device was fractured away.It is unknown whether the event happened during surgery and if there was patient involvement and if there was a back-up device available or if there was a delay.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A suturefix curved anchor insertion device was returned.The insertion device is missing the button and trigger from the handle and the nose tube and suture cover are damaged; the entire distal end of the device is fractured away.The suture anchor and associated suture strings were not returned.There is biological debris on the device.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.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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: SUTUREFIX CRV AHR S 2 #1 UB STR BL BL-CB
• 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: 19032665
• Report Number: 1219602-2024-00683
• Device Sequence Number: 12510561
• Product Code: MBI
• UDI-Device Identifier: 00885556686263
• UDI-Public: 885556686263
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K163034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72204689
• Device Lot Number: 2103748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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
• Patient Sex: Unknown