MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOSCOPIC CANN DRILL BIT 7MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	013660
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a rust on the drill bit.No patient injuries or delay were reported as the failure was found after the surgery.
Additional Manufacturer Narrative
Device has not been returned for examination, however a photograph was supplied.Review of the photograph confirmed the reported rusting like oxidation.The drills are water stained and contaminated with what appears to be human matter likely causing the observed oxidation.The most common cause of rust formation on stainless steel is improper cleaning.If the product is returned in the future the complaint can be reopened and evaluated.Initial reporter occupation: physician.

• Brand Name: ENDOSCOPIC CANN DRILL BIT 7MM
• 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: 8554845
• Report Number: 1219602-2019-00471
• Device Sequence Number: 1586470
• Product Code: HWE
• UDI-Device Identifier: 03596010091611
• UDI-Public: 03596010091611
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 06/18/2019

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: 013660
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1