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	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during use instruments inside the patient, the ultra fast-fix reverse curved implant failed to deploy, even though the surgeon used this correctly.The t2 implant got stuck at the distal tip of the needle and couldn't be pushed through, even with force outside of the joint space after the case finished.The procedure was completed with a s+n back-up device.No significant delay was reported, and no other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3, h6: the reported device, used in treatment, 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 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 review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.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 evaluation will be reopened for investigation.
Additional Manufacturer Narrative
H10: h2: correction on b2 and h6 "health impact code".

• 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: 12132225
• Report Number: 1219602-2021-01527
• Device Sequence Number: 11690749
• Product Code: GAT
• UDI-Device Identifier: 03596010597212
• UDI-Public: 03596010597212
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2022

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: 06/29/2025
• Device Model Number: 72201492
• Device Catalogue Number: 72201492
• Device Lot Number: 2033552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 07/12/2021; 12/20/2022
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 07/13/2021; 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• 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; Required Intervention
• Patient Sex: Unknown