MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIBIAL DRILL W/ STOP; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	00578904900
Medical Device Problem Codes	Break (1069); Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tka it was noticed drill was dull and needed to be sharpened.No delay, no injury, backup available not from smith and nephew.Surgery finished freehand.
Additional Manufacturer Narrative
The associated tibial drill and precoat femoral drill were returned and evaluated.A visual inspection confirmed the stated failure mode.The cutting flutes of the drills are dull and have burrs.These instruments were manufactured in 2005 and 2016 and they show significant signs of use.Our investigation could not determine a specific cause of the failure.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: TIBIAL DRILL W/ STOP
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8205049
• Report Number: 1020279-2018-02937
• Device Sequence Number: 18887890
• Product Code: MDM
• UDI-Device Identifier: 00885556618851
• UDI-Public: 00885556618851
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 00578904900
• Device Lot Number: 60297689
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018; 12/04/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 12/28/2018; 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1