MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRA FAST-FIX ASSY - REVERSE CURVE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	72201492
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a meniscal repair procedure, the t2 of the ultra fast-fix could not be deployed.T1 was successfully removed from the patient.The procedure was completed with non-significant delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
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 the customer provided first image revealed the chart-stiks and provides nothing additional to the complaint.A second image reveals the device with both anchors detached from the needle and not visible in the image.The suture is imaged and no physical damage is visible to either the suture or handheld device.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The instructions for use was 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.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.
Additional Manufacturer Narrative
H10: h3, h6: part of the reported device was received for evaluation.A review of the customer provided first image revealed the chart-stiks and provides nothing additional to the complaint.A second image reveals the device with both anchors detached from the needle and not visible in the image.The suture is imaged and no physical damage is visible to either the suture or handheld device.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The instructions for use was 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection revealed the device was recieved outside of original packaging.The anchors were not returned with the device.A cut piece of suture was returned with the device.No physical damage visible to the needle.The actuator was fully triggered.A functional evaluation revealed the actuator functions as expected.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed and the root cause could not be established since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: ULTRA FAST-FIX ASSY - REVERSE CURVE
• 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: 13193272
• Report Number: 1219602-2022-00044
• Device Sequence Number: 17607559
• Product Code: GAT
• UDI-Device Identifier: 03596010597212
• UDI-Public: 03596010597212
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K072322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2022

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 Expiration Date: 11/21/2025
• Device Model Number: 72201492
• Device Catalogue Number: 72201492
• Device Lot Number: 2064139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 02/11/2022; 07/01/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/14/2022; 07/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2020
• 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: Male