MAUDE Adverse Event Report: SMITH NEPHEW ORTHO HIP PLATE ACCRD STANDARD T

Model Number 71340013

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/05/2017

Event Type  Injury  

Event Description

Hardware failure.

• Brand Name: HIP PLATE ACCRD STANDARD T
• Type of Device: HIP PLATE ACCRD STANDARD T
• Manufacturer (Section D): SMITH NEPHEW ORTHO; st. louis MO 63141
• MDR Report Key: 6479949
• MDR Text Key: 72590058
• Report Number: MW5069000
• Device Sequence Number: 1
• Product Code: JDQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2017

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 Model Number: 71340013
• Device Lot Number: 10ESM0119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2017
• 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 Outcome(s): Hospitalization
• Patient Weight: 113