MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE, ENDOSCPC, CANN, 5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72202972
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter foreign zip code: (b)(6).
Event or Problem Description
It was reported that during a procedure at the time of introducing the drill flexible device to start drilling, the product broke.The incident happened inside the patient, however the device was removed.The patient´s health condition is stable and no damage was reported.The procedure was completed successfully with a backup device.
Additional Manufacturer Narrative
Due no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.

• Brand Name: DRILL, FLEXIBLE, ENDOSCPC, CANN, 5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6915219
• Report Number: 1219602-2017-01241
• Device Sequence Number: 827591
• Product Code: NBH
• UDI-Device Identifier: 03596010654533
• UDI-Public: (01)03596010654533(10)50541044
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2017

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: 72202972
• Device Catalogue Number: 72202972
• Device Lot Number: 50541044
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1