MAUDE Adverse Event Report: SMITH AND NEPHEW SMITH AND NEPHEW RULER GUIDE AND ROD FROM THE TRIGEN BASE INSTRUMENT FOR INTRAME; ROD FIXATION

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 11/14/2017

Event Type  malfunction  

Event Description

During the surgical procedure the surgeon noticed foreign objects on a surgical instrument.The instrument was from a vendor (smith and nephew).Use of the instrument was discontinued and the surgeon changed gloves.Instrument was picked up by (b)(4) (smith and nephew) on (b)(6) 2017.

• Brand Name: SMITH AND NEPHEW RULER GUIDE AND ROD FROM THE TRIGEN BASE INSTRUMENT FOR INTRAME
• Type of Device: ROD FIXATION
• Manufacturer (Section D): SMITH AND NEPHEW; fort worth TX 76100
• MDR Report Key: 7086314
• MDR Text Key: 94133163
• Report Number: MW5073746
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 43