MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM SURESHOT SHORT AO DRILL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71692810
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the surgeon inserted the drill at the distal nail ml screw hole and the drill was interfering with the nail, so the surgeon stopped drilling and removed the drill, then he found that something black had been attached to the drill.The surgeon had to drilled by hand and inserted the screw.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual examination of the returned sure shot drill indicated wear to the flutes from attempted use.This is a single use device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated that it was communicated via email that the procedure was completed with the surgeon drilling by hand.There was no extension of surgery time and no patient harm or injury is being reported as a result of this device related incident.Based on the provided information, no further clinical assessment is warranted.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: 4.0MM SURESHOT SHORT AO DRILL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis 38116
• MDR Report Key: 7603775
• Report Number: 1020279-2018-01120
• Device Sequence Number: 19256173
• Product Code: OLO
• UDI-Device Identifier: 03596010648242
• UDI-Public: 03596010648242
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/06/2023

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: 07/02/2026
• Device Model Number: 71692810
• Device Catalogue Number: 71692810
• Device Lot Number: 16BNG0001B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018; 04/27/2018; 05/06/2023
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 06/20/2018; 07/13/2018; 05/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown