MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR DYSPLASIA DRILL 3.2MM; BIT, DRILL

Catalog Number	90127619
Medical Device Problem Codes	Use of Device Problem (1670); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dysplasia pilot drill broke during the case.

• Brand Name: BHR DYSPLASIA DRILL 3.2MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 7315701
• Report Number: 3005975929-2018-00075
• Device Sequence Number: 10789286
• Product Code: HTW
• UDI-Device Identifier: 03596010533562
• UDI-Public: 03596010533562
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2018

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: 90127619
• Device Lot Number: 165390001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 11/23/2018
• Patient Sequence Number: 1