MAUDE Adverse Event Report: SMALL BONE INNOVATIONS, INC. REMOTION TOTAL WRIST

Model Number WA/R-LL

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Information (3190)

Event Date 02/25/2015

Event Type  Injury  

Event Description

Inner and outer pouches were perforated.

Manufacturer Narrative

Inner and outer pouches were perforated.Hosp flashed device and implanted.This is an isolated event.

• Brand Name: REMOTION TOTAL WRIST
• Manufacturer (Section D): SMALL BONE INNOVATIONS, INC.; morrisville PA
• Manufacturer Contact: steve ward ; 1380 s. pennsylvania ave.; morrisville, PA 19067 ; 2153376481
• MDR Report Key: 4658382
• MDR Text Key: 5599800
• Report Number: 3003640913-2015-00007
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K021859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Model Number: WA/R-LL
• Device Lot Number: 19955-S2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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
• Patient Outcome(s): Required Intervention