MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCOPIC CANN 10MM; BIT, DRILL

Catalog Number	7209739
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an acl reconstruction, the head of the 10.0 mm clancy flexible drill broke off in the femur when drilling.The piece was retrieved from the bone using a grasper.A 9.5 mm back-up device was used to drill the same tunnel to finish the case.The surgery was delayed less than 10 minutes.The patient did not experience any kind of damage.
Additional Manufacturer Narrative
A 7209739 flexible 10mm endoscopic cannulated drill reported on.This was a two year old reusable instrument.Based upon the information provided, the drill broke during procedure.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.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.

• Brand Name: DRILL FLEXIBLE ENDOSCOPIC CANN 10MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8619951
• Report Number: 1219602-2019-00562
• Device Sequence Number: 16666798
• Product Code: HTW
• UDI-Device Identifier: 03596010541970
• UDI-Public: 03596010541970
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 7209739
• Device Lot Number: 50648908
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR