MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE,ENDOSCOPIC,CANN, 8MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	7209737
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device reamer broke when it contacted the bone.No patient injury reported.
Additional Manufacturer Narrative
One 8mm endoscopic cannulated flexible drill was returned for evaluation.Visual assessment of the drill confirmed the reported breakage.The drill head has broken off from 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.

• Brand Name: DRILL, FLEXIBLE,ENDOSCOPIC,CANN, 8MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7079566
• Report Number: 1219602-2017-01506
• Device Sequence Number: 11246273
• Product Code: HWE
• UDI-Device Identifier: 03596010541987
• UDI-Public: (01)03596010541987(10)50561177
• Combination Product (Y/N): N
• 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): 01/30/2018

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: 7209737
• Device Catalogue Number: 7209737
• Device Lot Number: 50561177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1