MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REAMER; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 03/03/2011

Event Type  Injury  

Event Description

It was reported that during surgery there was a femoral perforation with the straight reamer.

Manufacturer Narrative

The associated complaint device was not returned.The clinical medical team concluded, this complaint is from a retrospective study in australia and identified during data cleaning in may 2018.Several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: REAMER
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7608421
• MDR Text Key: 111294398
• Report Number: 1020279-2018-01142
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 57