MAUDE Adverse Event Report: STRYKER TRAUMA GMBH/HOWMEDICA OSTEONICS CORP. T2; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1847-0001S

Device Problem Device Expiration Issue (1216)

Patient Problem Unspecified Infection (1930)

Event Date 01/20/2016

Event Type  Injury  

Event Description

Outdated orthopedic hardware implanted during surgery.Hardware expired 12/2014 and sterilization date was 01/2010.This was noticed after it was implanted.Infection control will be monitoring patient and infectious disease was notified.

• Brand Name: T2
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA GMBH/HOWMEDICA OSTEONICS CORP.; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5465995
• MDR Text Key: 39207215
• Report Number: 5465995
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2014
• Device Model Number: 1847-0001S
• Device Catalogue Number: 1847-0001S
• Device Lot Number: K201687
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2016
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER ORTHOPEDIC HARDWARE
• Patient Age: 38 YR