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)

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

Event Date 04/03/2014

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the remaining portion of the needle shows some minor scratches along the surface which is indicative of normal use.There is no observed damage to the device other than the broken tip.No cause for the failure could be determined.A review of the device history records was performed which confirmed no inconsistencies.A complaint history review has not identified additional complaints for this lot number on file.

Event Description

During a rotator cuff repair utilizing the truepass needle, it was reported that the tip broke off the device.It was retrieved and no patient complications were 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 ; 5123585706
• MDR Report Key: 5971717
• MDR Text Key: 55441948
• Report Number: 1219602-2016-00898
• 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: 04/03/2014

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: 01/31/2016
• Device Catalogue Number: 72203793
• Device Lot Number: 50491215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2014
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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