MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.7MM SHORT DRILL {} BIT W/QC; PLATE, FIXATION, BONE

Catalog Number	71173502
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon was performing the procedure and during the drilling, the drill bit broke inside of the patient's tibia.Postoperative fluoro and x-rays show the retained broken drill bit.
Event or Problem Description
This event occurred during an open reduction internal fixation with fluoroscopic-aided.Surgeon does not believe that a revision surgery is needed.

• Brand Name: 2.7MM SHORT DRILL {} BIT W/QC
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6849214
• Report Number: 1020279-2017-00718
• Device Sequence Number: 65294
• Product Code: HRS
• UDI-Device Identifier: 03596010519702
• UDI-Public: 03596010519702
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/07/2017

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 Expiration Date: 10/29/2023
• Device Catalogue Number: 71173502
• Device Lot Number: 13KM23793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 08/29/2017; 08/29/2017; 08/29/2017; 08/29/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 09/14/2017; 09/21/2017; 10/23/2017; 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Weight: 82