MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5330018
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
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
It was reported that the patient underwent revision surgery due to non-union.Intra-op, tip of the driver stripped.No patient complications were reported.
Additional Manufacturer Narrative
Additional information: product analysis: after visual, optical and functional evaluation, no evidence was found that would suggest a defect in manufacturing or processing of the driver.Functional evaluation with a sample mas screw appears to be able to be fully engaged into the mas head without issue.The lock driver appears to be capable of performing its intended function.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9222923
• Report Number: 1030489-2019-01188
• Device Sequence Number: 1934840
• Product Code: HBE
• UDI-Device Identifier: 00763000025199
• UDI-Public: 00763000025199
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182436
• 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,Followup
• Report Date (Section B): 12/11/2019

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 Catalogue Number: 5330018
• Device Lot Number: EM18J012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR