MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. PROBE HOLT T-HANDLE

Model Number SW12B120

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/11/2022

Event Type  malfunction  

Event Description

Per the operative report: the vertebral bodies from t11-l1 were extraordinarily sclerotic and in fact a t-handled probe tip broke off into the left side of the t12 vertebral body with left t12 pedicle probing.The fragment was left in place as it was causing no harm and it would have required complete obliteration of the pedicle for retrieving.Fda safety report id# (b)(4).

• Brand Name: PROBE HOLT T-HANDLE
• Type of Device: PROBE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 15241971
• MDR Text Key: 298167548
• Report Number: MW5111505
• Device Sequence Number: 1
• Product Code: HXB
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW12B120
• Device Catalogue Number: 803-290
• Device Lot Number: SW12B120
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic