MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCOPIC CANN 10MM; BIT, DRILL

Catalog Number	7209739
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a acl surgery the drill bit broke in half while reaming in the femoral tunnel, all the pieces were removed from the patient.There was a significant delay in the procedure but no patient injuries were reported, the procedure was completed with a back up device.
Additional Manufacturer Narrative
One 7209739 flexible 10mm endoscopic cannulated drill returned.This is a four year old reusable drill.The spiral flex portion has been stressed from torque and has been fractured.The cannula lumen is damaged.There are dings and gouges on the blade edges.The distal tip lumen has been skewed and is out of round.The damage is consistent with an axial alignment issue and contact with other instruments or devices.Use of drills with that have worn or dull tips can result in breakage.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.No root cause related to the manufacture of this device can be determined.

• Brand Name: DRILL FLEXIBLE ENDOSCOPIC CANN 10MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8479062
• Report Number: 1219602-2019-00380
• Device Sequence Number: 13928160
• Product Code: HTW
• UDI-Device Identifier: 03596010541970
• UDI-Public: 03596010541970
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: 7209739
• Device Lot Number: 50578042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1