MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWIST DRILL 2.0MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	210439
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during surgery a portion of drill bit broke off in the patient right side.(2.0 drill bit approx.2.2 cm).An x-ray was obtained per physician.It was determined that the drill bit was in the bone and not going to migrate therefore it would be left in and not removed.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please review attached for investigation results.(b)(4).

• Brand Name: TWIST DRILL 2.0MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6601507
• Report Number: 1020279-2017-00380
• Device Sequence Number: 712882
• Product Code: KTT
• UDI-Device Identifier: 03596010102560
• UDI-Public: 03596010102560
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

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: 210439
• Device Lot Number: 17CM02627
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 10/12/2017
• 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: Other