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

Catalog Number 72203793

Device Problems Break (1069); Component Falling (1105)

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

Event Date 03/12/2014

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the specific device reported by the complainant was not possible, as the device has not been returned.Review of the device history record was performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.Due to these facts, we are unable to determine what may have caused the user to experience the reported incident.

Event Description

It was reported that during a procedure using a truepass suture passer, the needle tip broke off when passing the suture.The piece was able to be removed with suction and a backup device was used to complete the procedure.There were no patient complications reported as a result of this event.

• 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: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5971474
• MDR Text Key: 55694952
• Report Number: 1219602-2016-00894
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2014

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: 11/30/2015
• Device Catalogue Number: 72203793
• Device Lot Number: 50483562
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 09/22/2016
• Date Device Manufactured: 11/21/2013
• 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