N/A 803-290Recalls & reported problems

Medtronic Sofamor Danek, Inc. · INSTRUMENT 803-290 THANDLE HOLT PROBE · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00673978035475), received between Aug 11, 2021 and Aug 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Break1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 11, 2021Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING DRIVER AND PROBE FOR AN OPEN TLIF. IT WAS REPORTED THAT THE DRIVER AND PROBE WERE BROKEN. THERE WERE NO FRAGMENTS OF THE INSTRUMENTS REMAINING IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE-OP DIAGNOSIS WAS SPINAL REVISION AND LEVELS IMPLANTED WERE T10-ILLIAC. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12305770 ↗

Device details

UDI-DI	`00673978035475`
Brand	N/A
Model	803-290
Company	Medtronic Sofamor Danek, Inc.
Product code	HXB · PROBE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 3, 2023

Device type (GMDN): Orthopaedic prosthesis implantation positioning instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Other PROBE devices

EXPEDIUM 279702030
Depuy Spine, LLC · PROBE
53 reports
Sklar Instruments 94-5923
Sklar Corporation · PROBE
1 recall0 reports
Sklar 96-2361
Sklar Corporation · PROBE
1 recall0 reports
MOSS 275010140
Depuy Spine, LLC · PROBE
28 reports
EXPEDIUM 279702040
Depuy Spine, LLC · PROBE
21 reports
MULTILOC 03.019.029
Synthes GmbH · PROBE
15 reports
MOSS 275010160
Depuy Spine, LLC · PROBE
11 reports
EXPEDIUM 279702010
Depuy Spine, LLC · PROBE
9 reports

All PROBE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page