MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. HOURGLASS SHAVER; TRAY, SURGICAL, INSTRUMENT

Lot Number MA06M044

Device Problems Use of Device Problem (1670); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Surgeon using instrument tapping in with just hand and 8mm hourglass shaver.

• Brand Name: HOURGLASS SHAVER
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 16324329
• MDR Text Key: 309257394
• Report Number: MW5114777
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: MA06M044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female