MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE, CANNULATED, 9.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72203165
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon drilled the fem tunnel to appropriate length and proceeded to keep drill in forward and back out the tunnel.The drill was moving out smoothly with no torquing on bit.A few millimeters before tunnel aperture, the distal tip of reamer between tip and flexible shaft snapped in 2 pieces.(b)(6) was used to pull and dislodge both pieces, delaying case by several minutes.
Additional Manufacturer Narrative
A 72203165 flexible 9.5mm cannulated drill reported on.This is a reusable instrument.The complaint stated: ¿the distal tip of reamer between tip and flexible shaft snapped in 2 pieces.¿ product was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Final product met predetermined specifications upon release to distribution.

• Brand Name: DRILL, FLEXIBLE, CANNULATED, 9.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8061232
• Report Number: 1219602-2018-01519
• Device Sequence Number: 1593215
• Product Code: NBH
• UDI-Device Identifier: 03596010654588
• UDI-Public: 03596010654588
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/13/2018

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: 72203165
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR