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

Model Number 72201491

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 09/10/2018

Event Type  malfunction  

Event Description

It was reported that during the meniscus repair surgery,after opening the package and cutting out the limiting deep sleeve, surgeon found that there was a protrusion of the suture between the two ts.As a result, the second t was also taken out after the first needle was inserted.There was a surgical delay greater than 30 minutes.

Manufacturer Narrative

One curved ultra fast-fix assembly was returned for evaluation.Visual assessment showed the depth straw has been trimmed to the surgeons desired length.No ts or suture remain on the delivery needle but were returned.Examination of the construct showed it has been cinched, no abnormalities were observed with the suture or ts.This investigation could not identify any evidence of product contribution to the reported complaint.

• 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 ; 5123585706
• MDR Report Key: 7882982
• MDR Text Key: 120554775
• Report Number: 1219602-2018-01261
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010597205
• UDI-Public: (01)03596010597205(17)211219(10)50637332
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2021
• Device Model Number: 72201491
• Device Catalogue Number: 72201491
• Device Lot Number: 50637332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2016
• 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
• Patient Age: 27 YR
• Patient Weight: 65