MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUEPASS NEEDLE SINGLE PACK STERILE BX 5; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72203793

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the truepass suture passer self-capture and truepass needle would not catch the suture.It was noted that the surgeon was trying to fire the suture through the tissue and the suture would not catch.Surgeon used a competitors device to finish case.A ten minute delay was noted and no patient impact.

Manufacturer Narrative

Device investigation narrative - one truepass needle and one truepass suture passer w/self-capture feature were returned for evaluation for the complaint of not passing suture properly.Device was functionally tested with the needle and a piece of ultrabraid suture, the needle was able to pick up the suture and the self-capture feature captured the suture as intended.Reported complaint of not passing suture properly could not be replicated.No further investigation is warranted at this time.Device evaluated by the manufacturer.(b)(4).

• Brand Name: TRUEPASS NEEDLE SINGLE PACK STERILE BX 5
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5773230
• MDR Text Key: 49639219
• Report Number: 1219602-2016-00341
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2020
• Device Catalogue Number: 72203793
• Device Lot Number: 50554715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2015
• 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