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

Model Number	7209739
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 10mm endoscopic cannulated flexible drill was returned for evaluation.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.The drill head chamfer is not visible.Further examination of the drill head showed the primary cutting surface and flutes are worn.Material condition was confirmed to meet print specification.Per the devices ifu ¿use of drills that have worn or dull tips can result in breakage¿.Further investigation is not warranted at this time.(b)(4).
Event or Problem Description
It was reported that the flexible drill reamer broke during the procedure.The broken piece was removed from the patient.A backup device was used to complete the surgery without patient impact following a short delay.

• 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: 6723544
• Report Number: 1219602-2017-00771
• Device Sequence Number: 13769920
• Product Code: HTW
• UDI-Device Identifier: 03596010541970
• UDI-Public: (01)03596010541970(10)50513283
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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: 7209739
• Device Catalogue Number: 7209739
• Device Lot Number: 50513283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1