MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRSPR CUPD 3.4MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 011014

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 02/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a piece broke off of it.

• Brand Name: GRSPR CUPD 3.4MM
• 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
• MDR Report Key: 6953207
• MDR Text Key: 89737115
• Report Number: 1219602-2017-01303
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/16/2017

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 Catalogue Number: 011014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 10/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1