MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS BHR SLEEVE CUTTER SIZE 54; GUIDE BAR

Catalog Number 90127601

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 10/07/2015

Event Type  Injury  

Event Description

Whilst surgeon was performing the step of preparing the femoral head, the sleeve cutter was placed over the guide bar.Once this was removed the surgeon noticed a piece of the guide bar was missing.As a result, slightly more bone was removed posteriorly of the femoral head.The missing piece to the guide bar was attached and the rest of the procedure was completed as per technique.Post operation x-rays were reportedly good.

Manufacturer Narrative

(b)(4).

Event Description

Surgery was extended by 15 to 30 minutes.

• Brand Name: BHR SLEEVE CUTTER SIZE 54
• Type of Device: GUIDE BAR
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; st. petersburg, FL 33716
• MDR Report Key: 5197058
• MDR Text Key: 30224325
• Report Number: 3005477969-2015-00290
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90127601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability