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	Rupture (2208)
Date of Event	07/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy, the suturefix ultra anchor got pulled out of the guide hole when the surgeon pulled it.The procedure was completed with a non-significant delay using a s+n back up device in a new drilled bone hole.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10 h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 customer provided undated image of the device does not indicate a root cause for the reported events.Based on the information provided no clinical factors were found which would have contributed to the reported events.No further risk to the patient is anticipated as a result of the additional bone hole.An analysis of the customer provided image found the suture anchor off the suture, the suture off the device, and the device on a surface.The root cause of the reported event could not be determined.Factors that could have contributed to the failure include rotation of the suture anchor device once seated or incomplete anchor insertion.No containment or corrective actions are recommended at this time.

• 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: 17393303
• Report Number: 1219602-2023-01336
• Device Sequence Number: 12997288
• 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): 11/19/2023

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: 2084178
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 11/19/2023
• Date Device Manufactured: 11/24/2021
• 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 Age: 28 YR
• Patient Sex: Male