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

Model Number 72201491

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 01/24/2018

Event Type  malfunction  

Event Description

It was reported that during the surgery, when cutting the suture, t1 and t2 fell off together, both were removed.Finally a backup device was used to complete the surgery.No significant delay or patient injury reported.

Manufacturer Narrative

One curved ultra fast-fix assembly was returned for evaluation.Visual assessment showed the trigger has been fully advanced and locked within the handle indicating a complete deployment.No suture or ts were returned for examination.The depth limiter has been trimmed to the surgeons desired length.This investigation could not identify any evidence of product contribution to the reported complaint.Further investigation is not required at this time.

• 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: 7283306
• MDR Text Key: 100654970
• Report Number: 1219602-2018-00245
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010597205
• UDI-Public: (01)03596010597205(17)220411(10)50658027
• 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: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2022
• Device Model Number: 72201491
• Device Catalogue Number: 72201491
• Device Lot Number: 50658027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2017
• 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: 18 YR
• Patient Weight: 70