MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC STRAIGHT HOLT PROBE; PROBE (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT)

Model Number 803-292

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 08/21/2020

Event Type  malfunction  

Event Description

Tip of the ball tip probe broke off inside the surgical site.

• Brand Name: STRAIGHT HOLT PROBE
• Type of Device: PROBE (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT)
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 10778596
• MDR Text Key: 214593872
• Report Number: 10778596
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 803-292
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29565 DA
• Patient Weight: 89