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

Catalog Number 72201491

Device Problem Device Fell (4014)

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

Event Date 07/14/2018

Event Type  malfunction  

Event Description

It was reported that after t1 and t2 implantation, t2 fell out.A backup device was available to complete the procedure with no significant delay and no patient injuries.

Manufacturer Narrative

One curved ultra fast-fix assembly was returned for evaluation.Visual assessment showed the depth limiter has been trimmed to the surgeons desired length.The trigger is fully advanced and locked within the handle.No ts or suture remain on the needle, however a 12 inch length of suture was returned.Examination of the suture showed no abnormalities.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: 7841834
• MDR Text Key: 119328324
• Report Number: 1219602-2018-01169
• Device Sequence Number: 1
• Product Code: JDR
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2019
• Device Catalogue Number: 72201491
• Device Lot Number: 50518954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2014
• 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: 45 YR