Jet-X 71067372Recalls & reported problems
Smith & Nephew, Inc. · JET-X QUICK CLAMP 10.5MM TO 5MM · Class 2 · Implant
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010607867), received between Aug 12, 2019 and Nov 9, 2021 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Mechanics Altered8
- Physical Resistance/Sticking8
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2021Break; Mechanics Altered; Physical Resistance/Sticking; Break; Mechanics Altered; Physical Resistance/Sticking
IT WAS REPORTED THAT AN JET-X QUICK CLAMP 10.5MM TO 5MM IS BROKEN, DOES NOT CLAMP AND IS STUCK. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783575 ↗MalfunctionNov 9, 2021Break; Mechanics Altered; Physical Resistance/Sticking; Break; Mechanics Altered; Physical Resistance/Sticking
IT WAS REPORTED THAT AN JET-X QUICK CLAMP 10.5MM TO 5MM IS BROKEN, DOES NOT CLAMP AND IS STUCK. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783564 ↗MalfunctionNov 9, 2021Break; Mechanics Altered; Physical Resistance/Sticking; Break; Mechanics Altered; Physical Resistance/Sticking
IT WAS REPORTED THAT AN JET-X QUICK CLAMP 10.5MM TO 5MM IS BROKEN, DOES NOT CLAMP AND IS STUCK. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783361 ↗MalfunctionNov 9, 2021Break; Mechanics Altered; Physical Resistance/Sticking; Break; Mechanics Altered; Physical Resistance/Sticking
IT WAS REPORTED THAT AN JET-X QUICK CLAMP 10.5MM TO 5MM IS BROKEN, DOES NOT CLAMP AND IS STUCK. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783354 ↗MalfunctionNov 9, 2021Break; Mechanics Altered; Physical Resistance/Sticking; Break; Mechanics Altered; Physical Resistance/Sticking
IT WAS REPORTED THAT AN JET-X QUICK CLAMP 10.5MM TO 5MM IS BROKEN, DOES NOT CLAMP AND IS STUCK. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783120 ↗MalfunctionNov 9, 2021Break; Mechanics Altered; Physical Resistance/Sticking; Break; Mechanics Altered; Physical Resistance/Sticking
IT WAS REPORTED THAT AN JET-X QUICK CLAMP 10.5MM TO 5MM IS BROKEN, DOES NOT CLAMP AND IS STUCK. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783118 ↗MalfunctionNov 9, 2021Break; Mechanics Altered; Physical Resistance/Sticking; Break; Mechanics Altered; Physical Resistance/Sticking
IT WAS REPORTED THAT AN JET-X QUICK CLAMP 10.5MM TO 5MM IS BROKEN, DOES NOT CLAMP AND IS STUCK. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783059 ↗MalfunctionNov 9, 2021Break; Mechanics Altered; Physical Resistance/Sticking; Break; Mechanics Altered; Physical Resistance/Sticking
IT WAS REPORTED THAT AN JET-X QUICK CLAMP 10.5MM TO 5MM IS BROKEN, DOES NOT CLAMP AND IS STUCK. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783058 ↗MalfunctionFeb 21, 2021Break; Break
IT WAS REPORTED THAT THE SURGEON WAS TIGHTENING THE NUT ON THE CLAMP, OUTSIDE THE PATIENT, THEN THE CLAMP BROKE AND FELL INTO PIECES. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11356710 ↗MalfunctionAug 12, 2019Break; Break
IT WAS REPORTED THAT DURING SURGERY, WHEN SURGEON TRIED TO TIGHTEN THE CLAMP, THE CLAMP SCREW SHEARED OFF. NO INJURY REPORTED AND ALL PIECES WERE RETRIEVED FROM PATIENT, THERE WAS NO DELAY AND A BACKUP DEVICE FROM SMITH AND NEPHEW WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8884272 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.