MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCOPIC CANN 8MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	7209737
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 8mm cannulated flexible endoscopic drill used for treatment, was returned for evaluation.This is an eight year old reusable tool.Per instructions for use: ¿the flexible drills are designed for limited reuse based upon the sharpness of the drill tip.Prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.¿ there was a relationship between the reported event and the device.The complaint stated: ¿the device broke in half in the middle of a case.¿ the primary cutting edges of the drill are dull and have visible dings.The spiral flex portion has been stressed from torque and has been fractured.No material voids were present at the fracture.Per instructions for use: ¿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.¿ complaint history review found no other reports for this lot number in the past five years.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.
Event or Problem Description
It was reported that during the surgery the device broke in half in the middle of a case.No delay or patient injury reported.It is unknown if there was a backup device available.

• Brand Name: DRILL FLEXIBLE ENDOSCOPIC CANN 8MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8759565
• Report Number: 1219602-2019-00776
• Device Sequence Number: 11148329
• Product Code: HWE
• UDI-Device Identifier: 03596010541987
• UDI-Public: 03596010541987
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 07/03/2019

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: 7209737
• Device Lot Number: 50358157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1