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

Catalog Number	71173503
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a drill bit broke during surgery and the tip was left in the patient.
Additional Manufacturer Narrative
Device was not evaluated due to the atual device was not returned for investigation.Please see investigation summary attached.(b)(4).

• Brand Name: 2.7MM 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: 6640416
• Report Number: 1020279-2017-00424
• Device Sequence Number: 613467
• Product Code: HRS
• UDI-Device Identifier: 03596010519719
• UDI-Public: 03596010519719
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

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 Catalogue Number: 71173503
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 09/29/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Weight: 65