MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT META STANDARD DRILL GUIDE PROBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71692814
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, warning message suggested metal interference had been displayed.There was no metal object within 20 cm field.Using radiolucent drill, the operation was continued.No impact or harm to patient.15 minutes delay.

• Brand Name: SURESHOT META STANDARD DRILL GUIDE PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8479052
• Report Number: 1020279-2019-01352
• Device Sequence Number: 1704345
• Product Code: OLO
• UDI-Device Identifier: 03596010648143
• UDI-Public: 03596010648143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71692814
• Device Catalogue Number: 71692814
• Device Lot Number: 18LK00013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 71