MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ZUK FEMORAL REAMER .270; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESSORY/ATTACHMENT

Catalog Number 00584305100

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2018

Event Type  malfunction  

Event Description

It was reported that during surgery the femoral drill is dull, needs excessive force to drill in.The drill was then stuck, could not get out.A delay less than 30 min was reported.A backup device was not available.No injury reported.

Manufacturer Narrative

The associated complaint device was not returned.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.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: ZUK FEMORAL REAMER .270
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8254307
• MDR Text Key: 133324972
• Report Number: 1020279-2019-00187
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00885556621646
• UDI-Public: 00885556621646
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00584305100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1