Polaris 5.5 Spinal Fixation System 2000-9082Recalls & reported problems

Highridge Medical, LLC · TORQUE INDICATING WRENCH · Class 1

All models of Polaris 5.5 Spinal Fixation System (8)

Data updated Oct 18, 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 03662663191906), received between Jun 4, 2026 and Jun 4, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture1
Material Twisted/Bent1

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.

MalfunctionJun 4, 2026Fracture; Material Twisted/Bent
IT WAS REPORTED THAT THE TIP OF A FINAL DRIVER TWISTED AND FRACTURED OFF INTRA-OPERATIVELY. THE SURGEON IMPROVISED DURING THE PROCEDURE, BUT THERE WERE NO PATIENT IMPACTS SINCE THERE WAS A BACKUP PLUG DRIVER AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25393808 ↗

Device details

UDI-DI	`03662663191906`
Brand	Polaris 5.5 Spinal Fixation System
Model	2000-9082
Company	Highridge Medical, LLC
Product code	HXC · WRENCH
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 24, 2025

Device type (GMDN): Surgical instrument handle, torque-limiting

A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Other WRENCH devices

MONARCH 277040510
Medos International Sàrl · WRENCH
199 reports
PINNACLE 2217-50-008
Depuy (Ireland) · WRENCH
108 reports
SIGMA 96-1673
Depuy (Ireland) · WRENCH
102 reports
P.F.C. 86-5189
Depuy (Ireland) · WRENCH
92 reports
Veptr 03.641.004
Synthes GmbH · WRENCH
86 reports
RECLAIM 2975-00-300
Depuy (Ireland) · WRENCH
51 reports
PINNACLE 2217-50-006
Depuy (Ireland) · WRENCH
34 reports
NA 388.261
Synthes GmbH · WRENCH
32 reports

All WRENCH 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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 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