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

Catalog Number 72202468

Device Problem Unintended Ejection (1234)

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

Event Date 08/06/2019

Event Type  malfunction  

Event Description

It was reported that during a procedure t2 pre-deploy.The procedure was successfully completed without any significant delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

One 72202468 fast-fix 360 curved needle delivery system device was used for treatment but was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were limited without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Influences that could compromise product performance or integrity that are unrelated to manufacture include: inadvertent twisting triggering deployment ring during removal from packaging use inconsistent with instructions for use recommendations.Inadvertent twisting or bending of the delivery needle.Incomplete needle penetration through meniscus.Difficulty with reaching the desired tissue location.Entanglement with other instruments or devices.Inadequate tissue conditions.Per instructions for use ¿do not push the deployment slider until the needle is fully penetrated through the meniscus.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.¿ product met specifications upon release to distribution.

Manufacturer Narrative

Two 72202468 fast-fix 360 curved needle delivery system devices reported on.They were used for treatment.Two shelf cartons were returned but only one had product returned inside for evaluation.Two complaints were created.The complaints stated: ¿t2 pre-deploy.¿ t1, t2 and suture were still within the needle track.The depth limiter was attached and had been adjusted.The delivery needle was bowed and noticeably bent toward the left.The device no longer cycled or actuated properly due to the damage.The deployment mechanism was cycled freeing t1 and t2 but it required assistance to retract back to position.The conditions align with difficulty in reaching intended anchoring location.Please note: inadvertent twisting or over flexing of the needle track can affect deployment and may encourage unintended release or retaining of anchors.Per instructions for use: ¿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 manufacture of the device was confirmed.Product met specifications upon release to distribution.

Manufacturer Narrative

Related device was reported on : 1219602-2019-01049.

• 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: 8952880
• MDR Text Key: 156306081
• Report Number: 1219602-2019-01048
• 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,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2020
• Device Catalogue Number: 72202468
• Device Lot Number: 50687956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1