MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST-FIX 360 STRAIGHT NDL DELIVERY SY; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	72202467
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during an arthroscopy, the t1 implant of a fast-fix 360 was deployed, however, t2 could not be deployed.Surgery was completed with a back-up device instead.There was a surgical delay of less than 30 minutes, and no further complications were reported.
Additional Manufacturer Narrative
H10: h6: a device deficiency was not identified, since the device was not returned for evaluation.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.The investigation did not identify a definitive root cause.However, probable causes for the reported failure in this event could include: (1) the application of unintended, inappropriate, or excessive force during device use, (2) user failure to fully actuate the device during the implantation process, and (3) tolerance variability in the bending process between the needle and actuator, which could have potentially caused the actuator to become stuck or slide below the implant, preventing it from properly picking up the implant for deployment.The manufacturing process was reviewed, and a process enhancement was implemented to reduce the variability in the bending process of the actuator and needle, thereby reducing the risk of a stuck actuator within the needle.Although this potential cause has been addressed, the investigation could not conclusively determine this as a definitive root cause.The risk management review confirmed that the reported failure is appropriately documented.The overall risk level is considered adequate.Therefore, no additional actions are deemed necessary at this time.

• Brand Name: FAST-FIX 360 STRAIGHT NDL DELIVERY SY
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 20170900
• Report Number: 1219602-2024-01955
• Device Sequence Number: 8031902
• Product Code: GAT
• UDI-Device Identifier: 00885554023060
• UDI-Public: 885554023060
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121861
• 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): 11/25/2024

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 Expiration Date: 08/10/2026
• Device Catalogue Number: 72202467
• Device Lot Number: 2128185
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 11/26/2024
• Date Device Manufactured: 08/10/2023
• 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