MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOSCOPIC CANN DRILL BIT 10MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 013663

Device Problem Degraded (1153)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2019

Event Type  malfunction  

Event Description

It was reported a rust on the drill bit.No patient injuries or delay were reported as the failure was found after the case.

Manufacturer Narrative

One 013663 cannulated endoscopic 10mm 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.Confirms instructions, precautionary statements and recommendations for proper use of product.¿these instruments are designed for repeated use with proper care and handling.¿ please refer to for instructions on automatic and manual sterilization recommendations.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.Further action is not required at this time.

• Brand Name: ENDOSCOPIC CANN DRILL BIT 10MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8520396
• MDR Text Key: 142250827
• Report Number: 1219602-2019-00434
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 03596010025203
• UDI-Public: 03596010025203
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 013663
• Device Lot Number: VSW62257/1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1