MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRA FAST-FIX ASSEMBLY - CURVED; STAPLE, FIXATION, BONE

Model Number 72201491

Device Problem Component Falling (1105)

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

Event Date 02/01/2018

Event Type  malfunction  

Event Description

It was reported that when doctor was doing a meniscus suture operation and used the first stitch for fastfix, the t1 fell off and the thread could not be hung.After that, the backup device was taken out to complete the operation.A delay less than 30 minutes was reported.No patient injuries were reported.

Manufacturer Narrative

Visual assessment to the returned device showed the depth straw has been trimmed to the surgeon¿s desired length.T1 was free from the needle but remains attached to the suture.T1 is missing its proximal end and it is soiled with human matter.The suture was frayed proximal to t1.T2 remains in its customary pre-deployment position on the insertion needle.T2 was fully advanced and tested for deployment using a rubber meniscus model, t2 deployed as intended.No root cause related to the manufacture of the device was established.

• Brand Name: ULTRA FAST-FIX ASSEMBLY - CURVED
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7487910
• MDR Text Key: 107565192
• Report Number: 1219602-2018-00535
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010597205
• UDI-Public: (01)03596010597205(17)210404(10)50594584
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2021
• Device Model Number: 72201491
• Device Catalogue Number: 72201491
• Device Lot Number: 50594584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1