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

Catalog Number	71173502
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during osteosynthesis of tibial plateau fractures, the surgery was performed according to the corresponding surgical technique but the drill bit was broken in the last block, with fragment ending up inside the patient.Surgeon decided not to retrieve the fragment.
Additional Manufacturer Narrative
A correction based on additional information received.
Additional Manufacturer Narrative
[(b)(4)].
Additional Manufacturer Narrative
A correction based on additional information received.
Event or Problem Description
Fragment is noted to be approximately 2.5cm in size and away from the joint area with little potential for movement.

• 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: 6986466
• Report Number: 1020279-2017-00939
• Device Sequence Number: 13478286
• Product Code: HRS
• UDI-Device Identifier: 03596010519702
• UDI-Public: 03596010519702
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/31/2018

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: 04/21/2025
• Device Catalogue Number: 71173502
• Device Lot Number: 16ANG0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 11/09/2017; 11/16/2017; 11/16/2017; 11/16/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 11/10/2017; 12/05/2017; 01/30/2018; 01/31/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Weight: 56