T2 1806-1600Recalls & reported problems
Stryker GmbH · Target Device GTN · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540682239), received between Mar 25, 2019 and Nov 6, 2022 — classified as 3 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
- Failure to Align1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2022Failure to Align; Failure to Align
AS REPORTED: "OPTION OF THE OBLIQUE LOCKING SCREW COULD NOT BE FILLED. THE DRILLING WITH THE 4.2MM DRILL WENT NORMALLY, BUT THE 5MM BOLT COULD NOT BE INSERTED COMPLETELY. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15741158 ↗MalfunctionSep 29, 2020Break; Break
IT WAS REPORTED BY THE SALES REP, "DURING A LEFT FEMUR FRACTURE, THE SURGEON WAS ASSORTING THE NAIL WITH A STRIKE PLATE ON AND WENT TO PULL DOWN ON THE GTN TARGETING DEVICE AND SNAPPED IT COMPLETELY OFF, THE PORTION THAT¿S ATTACHED TO NAIL. THE SURGEON ATTEMPTED TO PUT IT BACK ON TO THE BEST OF HIS ABILITY SO HE COULD ALIGN THE PROXIMAL WHOLES TO SHOOT THE PROXIMAL SCREWS, HE WAS ABLE TO DO SO, CAUSED A SEVERAL MINUTE DELAY".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10603337 ↗MalfunctionMar 25, 2019Fracture; Device Dislodged or Dislocated; Fracture
IT WAS REPORTED THAT THE NAIL TARGETING DEVICE DISASSOCIATED AT THE NECK. THE NAIL WAS UNUSABLE WITHOUT TARGETING DEVICE, THERE WAS A SURGICAL DELAY OF 7 MINUTES, AND AN ALTERNATE TYPE OF NAIL WAS USED AS A RESULT. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8448167 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
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 16, 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