MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC VANTAGE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	9339040
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via field representative regarding patient with pre-op diagnosis-t9-t10 infection involved in thoracic corpectomy procedure.Levels implanted- t9.It was reported that during procedure, the screwdriver was ¿stripped¿, would not hold screw.Instrument did not broke, deformed tip (stripped) hex driver tip.Product was utilized correctly according to the directions given in the ifu/labeling.On 2021-mar-08, received additional information that initial surgery was performed with original products, but not completed.On (b)(6) 2021, patient returned for additional surgery, inclusive of additional treatment to complete surgery from (b)(6) 2021.The surgery on (b)(6) 2021 was delayed while they tried to lock the vantage plate.Approximate delay was 30-45 minutes.No patient symptoms/complications reported.

• Brand Name: VANTAGE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11543577
• Report Number: 1030489-2021-00381
• Device Sequence Number: 17293800
• Product Code: LXH
• UDI-Device Identifier: 00721902692604
• UDI-Public: 00721902692604
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9339040
• Device Catalogue Number: 9339040
• Device Lot Number: JT03H002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2021
• Initial Report FDA Received Date: 03/22/2021
• 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: Required Intervention
• Patient Age: 64 YR