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	10/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke inside the patient, however, all pieces were removed from the patient.No patient injury or significant delay were reported.Back up was available to complete the procedure.
Additional Manufacturer Narrative
One 10mm endoscopic cannulated flexible drill was returned for evaluation.The drill is over four years old.Visual assessment confirmed the reported breakage.The drill has broken where it transitions from the 20 ½ to 9 revolutions per inch at the lazer cut double helix.No material voids are present at the break area.Rockwell testing confirmed the drill met print specification (rc 51.6).The primary cutting edges are dull and the cannulation is heavily burred.No root cause related to the manufacture of the device can be established.

• 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: 8070804
• Report Number: 1219602-2018-01554
• Device Sequence Number: 11353715
• Product Code: HTW
• UDI-Device Identifier: 03596010541970
• UDI-Public: 03596010541970
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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 Catalogue Number: 7209739
• Device Lot Number: 50356898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1