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

Model Number	7211005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that t1 and t2 deploy together during procedure.No patient injury was reported.Back-up device was available.
Additional Manufacturer Narrative
One fast-fix 360 curved needle delivery system was returned for evaluation.Visual assessment of the device shows approximately.762 of the needle tip has been broken off.The delivery needle is bent on two planes.No ts or suture were returned for evaluation.Device was functionally tested for proper actuator advancement and cycling, device would not function properly due to the observed damage.The condition of the device indicates it was subjected to excessive force.Per the device warnings "do not bend the delivery needle.The fast-fix 360 devices are manufactured with straight or curved delivery needles.Intentional bending of the delivery needle may make it difficult or impossible to deliver the t1 and t2 implants.If the delivery needle has been inadvertently bent, or if resistance is encountered during deployment, a new delivery device may be needed".No root cause related to the manufacturing process can be established.Corrected.

• Brand Name: FAST-FIX 360 CURVED NDL DELIVERY SYS
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7632631
• Report Number: 1219602-2018-00801
• Device Sequence Number: 19388554
• Product Code: GAT
• UDI-Device Identifier: 03596010543578
• UDI-Public: (01)03596010543578(17)201231(10)50705493
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K092508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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: 01/02/2021
• Device Model Number: 7211005
• Device Catalogue Number: 72202468
• Device Lot Number: 50705493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 06/24/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1