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

Catalog Number	013661
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
One 013661 cannulated endoscopic 8mm drill bit reported on.The product was not returned for evaluation.Physical conclusions, full investigation and evaluation were restricted.Factors affecting device performance include: device ability, surgical ability and surgical site preparation according to instructions for use.Instructions for use confirms instructions, precautionary statements and recommendations for proper use of product.Per instructions for use: ¿these instruments are designed for repeated use with proper care and handling.¿ please refer to instructions for use for instructions on automatic and manual sterilization recommendations.Per instructions for use: low-sudsing, neutral 6.0¿8.0 ph, enzymatic detergents are recommended.Do not use detergents above 11.0 ph.Use deionized water for washing and rinsing.There are no other complaints for this lot.This is considered an isolated instance.Allegation occurrence rate is monitored via surveillance.

• Brand Name: ENDOSCOPIC CANN DRILL BIT 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: 8520427
• Report Number: 1219602-2019-00435
• Device Sequence Number: 2675861
• Product Code: HWE
• UDI-Device Identifier: 03596010025173
• UDI-Public: 03596010025173
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• 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: 013661
• Device Lot Number: VSW57786
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 04/16/2019
• 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