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

Catalog Number	72202972
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when piercing the patient's femur with the drill, it broke in the middle.No patient injury or significant delay were reported.Back up device was available.
Additional Manufacturer Narrative
A 72202972 5mm flexible endoscopic cannulated drill used for treatment, was returned for evaluation.This was a five year old reusable instrument.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.The cutting edges have been dulled and dinged.The drill was snapped in two pieces where the spiral gradations increase.The flex drills are intended to flex but not be bent.Fracture may also occur if the drill is inadvertently put into reverse or if there are sudden starts and stops.There was also a hudson end portion of a separate drill chuck or instrument sent.The piece also indicates a torque factor.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
A 5 mm flexible endoscopic cannulated drill reported on.This was a five year old reusable instrument.Product was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were limited 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.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Influences that could compromise product performance or integrity that are unrelated to manufacture include: the instructions for use were not adhered to.Condition the driver¿s bit or chuck.Use of reverse rotation.Inadvertent torque, pressure, leverage and bending.Getting entangled up with other instruments or devices.Debris such as bone chips caught in the bit or chuck.Unexpected bone density/condition.Instrument blade dulling.Lack of recommended maintenance.Per instructions for use: ¿this is a limited reuse device based upon the sharpness of the drill tip.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¿.Product met specifications upon release to distribution.
Event or Problem Description
It was reported that, during an unspecified surgery, the drill broke in the middle while piercing the patient's femur.A back up device was available.No patient injury or significant delay were reported.

• 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: 8628389
• Report Number: 1219602-2019-00577
• Device Sequence Number: 19330813
• Product Code: NBH
• UDI-Device Identifier: 03596010654533
• UDI-Public: 03596010654533
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXCEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2019

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: 72202972
• Device Lot Number: 505109779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 06/17/2019; 09/05/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/18/2019; 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1