MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST-FIX 360 CRVD KPSC AND SLTD CAN.; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	72202675
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was report that during an acl procedure, three fast fix 360 curved had issues, the first one had a t1 pre-deployed, the second one had a simultaneous deployment and the third one had a problem and t1 was already implanted.The procedure was successfully completed without significant delay using a s+n back-up device.No patient injury or other complications were reported.
Event or Problem Description
It was report that during an acl procedure, one fast fix 360 curved had a simultaneous deployment.The procedure was successfully completed without significant delay using a s+n back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H2: additional information ¿b5¿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 the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.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 investigation will be reopened for evaluation.
Event or Problem Description
It was report that during an acl procedure, one fast fix 360 curved had a simultaneous deployment.The procedure was successfully completed without significant delay using a s+n back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Reassessment of this event identified that the device reported was a knot pusher/suture cutter that did not cut the device threads instead of a fast-fix with a simultaneous deployment failure.Additionally, no serious injury occurred nor medical intervention was required as a result of the event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: FAST-FIX 360 CRVD KPSC AND SLTD CAN.
• 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 ; 5123913905
• MDR Report Key: 12442676
• Report Number: 1219602-2021-01894
• Device Sequence Number: 14307933
• Product Code: GAT
• UDI-Device Identifier: 00885554023176
• UDI-Public: 00885554023176
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K092508
• 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,Followup,Followup
• Report Date (Section B): 05/02/2022

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: 07/14/2025
• Device Model Number: 72202675
• Device Catalogue Number: 72202675
• Device Lot Number: 2057295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 08/20/2021; 10/08/2021; 04/27/2022
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/10/2021; 10/12/2021; 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• 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: Required Intervention
• Patient Sex: Male