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

Catalog Number 72203793

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)

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

Event Date 02/20/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation, therefore a root cause for the breakage cannot be determined with confidence.A review of the device history records was performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.A complaint history review has not identified additional complaints for this lot number on file.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that during a procedure using a truepass needle, the needle broke halfway down the shaft and became lodged in the cuff.The piece was removed successfully.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: 5961116
• MDR Text Key: 55424199
• Report Number: 1219602-2016-00698
• 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: 02/20/2015

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: 01/31/2016
• Device Catalogue Number: 72203793
• Device Lot Number: 50491221
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 09/19/2016
• Date Device Manufactured: 01/29/2014
• 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