MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STERILE 6.4MM DRILL; PLATE, FIXATION, BONE

Model Number	71631035
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the femoral neck of the drill broke.In order to continue surgery, the primary nail and femoral neck had to be removed, which resulted in a 60 minutes delay in surgery.

• Brand Name: STERILE 6.4MM DRILL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6577975
• Report Number: 1020279-2017-00352
• Device Sequence Number: 882329
• Product Code: HRS
• UDI-Device Identifier: 03596010605962
• UDI-Public: 03596010605962
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71631035
• Device Catalogue Number: 71631035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/23/2017
• Supplement Date Received by Manufacturer: 04/23/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization