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

Model Number	72201490
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that t2 did not deployed.There was no delay or patient injury reported.
Additional Manufacturer Narrative
The blue split cannula was returned.The white depth limiter was returned untrimmed.T1 and t2 were returned.T1 had been previously freed from the needle tip.T2 was found situated at the tip of the delivery needle and partial suture remained inside the track.Visual inspection confirmed that the needle was straight and showed no damage.Functional evaluation confirmed that the manual advancement lever was fully advanced.T2 was successfully manually stripped off the needle tip with a gentle tug on the suture.This is the intended use for this product.No mechanical failure was found for the device returned.No root cause related to the manufacture of the device was confirmed.No further investigation is warranted.
Additional Manufacturer Narrative
Due to no product return the complaint could not be confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.No further actions pursued at this time.

• Brand Name: ULTRA FAST-FIX ASSEMBLY - STRAIGHT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7439901
• Report Number: 1219602-2018-00449
• Device Sequence Number: 1146640
• Product Code: GAT
• UDI-Device Identifier: 03596010610904
• UDI-Public: (01)03596010610904(17)191201(10)50525500
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K072322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2018

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: 12/01/2019
• Device Model Number: 72201490
• Device Catalogue Number: 72201490
• Device Lot Number: 50525500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/08/2018; 08/20/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/11/2018; 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1