MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST-FIX 360 CURVED NDL DELIVERY SYS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202674
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure using a fast fix 360 device, the t1 and t2 implants deployed simultaneously.The procedure was completed using a backup device.There were no significant delays or patient complications reported as a result of this event.
Additional Manufacturer Narrative
Device investigation narrative - three fast-fix 360 curved needle delivery systems were returned for evaluation.No ts or sutures were returned.Visual assessment showed the actuator on each device is in its post t2 deployment position indicating multiple deployment slider actuations and complete deployment.The devices were functionally tested for proper actuator advancement and cycling and were found to function as intended.Each device needle is slightly bent.Per the device ifu under warnings ¿do not push the deployment slider twice or the second implant will deploy prematurely¿.Further investigation is not warranted at this time.Device evaluated by the manufacturer.Evaluation codes updated.(b)(4).
Additional Manufacturer Narrative
Add health care professional.Device was not available for evaluation.Add check on other and populate (b)(4) as the country where incident happened.Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.

• Brand Name: FAST-FIX 360 CURVED NDL DELIVERY SYS
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6897526
• Report Number: 1219602-2017-01215
• Device Sequence Number: 1325428
• Product Code: MBI
• UDI-Device Identifier: 00885554023169
• UDI-Public: (01)00885554023169(17)220426(10)50660655
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K092508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2017

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 Model Number: 72202674
• Device Catalogue Number: 72202468
• Device Lot Number: 50660655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 09/15/2017; 11/08/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 10/30/2017; 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1