MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE, CANNULATED, 7.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72203163
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ligamentoplasty the 7.5mm clancy flexible drill cracked.It took about 50 minutes to remove the piece from the patient.
Additional Manufacturer Narrative
One (b)(4) flexible 7.5mm cannulated drill reported on.This is a three 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 or chuck.6.Unexpected bone density/condition.Never use the drill in reverse rotation.Only use the drill in forward rotation.Using the drill in reverse rotation may result in patient injury and/or failure of the instrument.This is a limited reuse device based upon the sharpness of the drill tip.As with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.Final product met specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: DRILL, FLEXIBLE, CANNULATED, 7.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8153144
• Report Number: 1219602-2018-01729
• Device Sequence Number: 13876606
• Product Code: NBH
• UDI-Device Identifier: 03596010654564
• UDI-Public: 03596010654564
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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: 72203163
• Device Lot Number: 50616864
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1