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	09/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported drill broke when preparing the bone tunnel.Broken pieces were removed from the patient.A backup device was available to complete the procedure.Delay was less than 30 minutes and no patient injuries were reported.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.
Additional Manufacturer Narrative
One 5mm flexible endoscopic drill was returned for evaluation.Visual assessment of the drill confirmed the reported breakage.Drill has broken where the double helix transitions to 9 revs per inch.No material voids are present at the break area.The drill shaft is bent.Further examination of the drill head showed the cannulation is heavily burred.The condition of the device indicates the drill was subjected to excessive forces during use.Per the device ifu under precautions ¿use of drills with that have worn or dull tips can result in breakage.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure¿.

• 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: 6846835
• Report Number: 1219602-2017-01087
• Device Sequence Number: 18954686
• Product Code: NBH
• UDI-Device Identifier: 03596010654533
• UDI-Public: (01)03596010654533(10)50559238
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2017

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: 50559238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 10/16/2017; 12/27/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 10/17/2017; 12/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR