Jet-X 71065458Recalls & reported problems
Smith & Nephew, Inc. · TiN 5MM X 45MM SHORT HALF PIN · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010487315), received between Jan 7, 2022 and Feb 7, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Rupture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2022Break; Break
IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, (2) JET-X TIN 5MM X 45MM SHORT HALF PINS BROKE OFF IN THE FEMUR. IT IS UNKNOWN IF/HOW SURGERY WAS COMPLETED, AND IF THERE WAS ANY DELAY. NO PATIENT INJURY REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13476730 ↗InjuryJan 7, 2022Break; Break
IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE TIN 5MM X 45MM SHORT HALF PIN BROKE INSIDE THE PATIENT'S BONE WHEN TIGHTENING. THE SURGEON USED THE SET OF THE BROKEN PIN TO REMOVE THE HALF PIN AND IT TOOK AROUND AN HOUR TO GET OUT THE BROKEN PIECE. THE PROCEDURE WAS FINISHED WITH A COMPETITOR'S DEVICE. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED.
Patient problems: Rupture
MAUDE report 13191902 ↗
Other PIN, FIXATION, THREADED devices
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- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- APEX 5038-1-080Stryker GmbH · PIN, FIXATION, THREADED48 reports
- Agee Digit Widget® DWD-232Hand Biomechanics Lab Inc · Pin, Fixation, Threaded32 reports
- SPATIAL FRAME 71070720Smith & Nephew, Inc. · PIN, FIXATION, THREADED15 reports
- APEX 5038-2-110Stryker GmbH · PIN, FIXATION, THREADED11 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.