MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL,FLEXIBLE,ENDOSCOPIC,CANN, 9MM; BIT, DRILL

Model Number	7209738
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the tip of the drill bit broke off in the patient.
Additional Manufacturer Narrative
One 9mm endoscopic cannulated flexible drill was returned for evaluation.The device is over three years old.Visual assessment of the drill confirmed the reported breakage.The drill head has broken off the shaft.The break is along the axis to the first spiral cut.There is tip flaring on the distal end of the drill head id.Further examination of the drill head showed the primary cutting surfaces are dull and damaged.Material condition was inspected and confirmed to meet print specification.Additional information.

• Brand Name: DRILL,FLEXIBLE,ENDOSCOPIC,CANN, 9MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7153312
• Report Number: 1219602-2017-01608
• Device Sequence Number: 13487843
• Product Code: HTW
• UDI-Device Identifier: 03596010541994
• UDI-Public: (01)03596010541994(10)50521965
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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 Model Number: 7209738
• Device Catalogue Number: 7209738
• Device Lot Number: 50521965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 65