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

Catalog Number 72202468

Device Problem Failure to Fire (2610)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2019

Event Type  malfunction  

Event Description

It was reported that during a lateral meniscus repair procedure the t1 was deployed successfully, but t2 could not be deployed.No patient injuries or delay reported.Back-up device was available to complete the surgery.

Manufacturer Narrative

One used fast-fix 360 curved needle delivery system was returned for evaluation.Visual assessment of the device showed no suture or ts remain on the delivery needle or were returned.The needle is dramatically bent on two planes.The actuator is in its lodged at the distal end of the delivery needle.The device was functionally tested for proper actuator advancement and cycling, device did not function as intended.Per the device instructions for use under 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.Do not push the deployment slider twice or the second implant will deploy prematurely¿.There were no indications that would suggest that the devices did not meet product specifications upon release into distribution.

Manufacturer Narrative

The reported fast-fix 360 curved needle delivery system intended for use in treatment, will not be returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, t2 would not deploy.An exact root cause cannot be determined with confidence without the return of the device, however, factors that could have contributed to the reported event include: bending of the delivery needle.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: FAST-FIX 360 CURVED NDL DELIVERY SYS
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8952882
• MDR Text Key: 156305710
• Report Number: 1219602-2019-01050
• Device Sequence Number: 1
• Product Code: GAT
• UDI-Device Identifier: 00885554023077
• UDI-Public: 00885554023077
• Combination Product (y/n): N
• PMA/PMN Number: K092508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2022
• Device Catalogue Number: 72202468
• Device Lot Number: 50784931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/31/2019
• Supplement Dates Manufacturer Received: 09/24/2019; 10/18/2019
• Supplement Dates FDA Received: 09/25/2019; 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1