MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE, CANNULATED, 8.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72203164
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sa was drilling femoral tunnel.She had just entered the femoral tunnel in forward full speed and was moving the drill slowly.She stopped drill to read the depth off of reamer.The surgeon noticed that the distal tip of reamer between tip and flexible shaft was being stretched.The surgeon commented, "once you start to drill, its going to snap again." and, that's exactly what happened.This is the second flexible reamer to snap in past six weeks.We went through all checkpoints of possible reasons for this and concluded it had to be an issue with the reamer.The reamer has only been used less than 5 times.A kelly was used to remove pieces and a backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
One (b)(4) 8.5mm cannulated flex drill flexible reported on.This is a six year old reusable instrument.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 1.Condition the driver¿s bit or chuck.2.Use of reverse rotation.3.Inadvertent torque, pressure, leverage and bending.4.Getting entangled up with other instruments or devices.5.Debris such as bone chips caught in the bit orchuck.6.Unexpected bone density/condition.7.Age of product.Final product met specifications upon release to distribution.

• Brand Name: DRILL, FLEXIBLE, CANNULATED, 8.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8156950
• Report Number: 1219602-2018-01742
• Device Sequence Number: 11355573
• Product Code: NBH
• UDI-Device Identifier: 03596010654571
• UDI-Public: 03596010654571
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2019

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: 72203164
• Device Lot Number: 50461501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR