Jet-XRecalls & reported problems across all models

We found 24 models of Jet-X by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2018 and Aug 8, 2025 — classified as 11 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Break” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Jet-X problems

Jet-X models

24 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Jet-X 71067372

  APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
  10 reports
• Jet-X 71067323

  APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
  7 reports
• Jet-X 71067322

  APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
  5 reports
• Jet-X 71062250

  PIN, FIXATION, THREADED
  3 reports
• Jet-X 71067382

  APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
  3 reports
• JET-X 71063027

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• Jet-X 71065401

  PIN, FIXATION, THREADED
  2 reports
• Jet-X 71065458

  PIN, FIXATION, THREADED
  2 reports
• Jet-X 71064002

  PIN, FIXATION, THREADED
  2 reports
• Jet-X 71064010

  PIN, FIXATION, THREADED
  2 reports
• Jet-X 71063028

  INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
  2 reports
• Jet-X 71067326

  Prosthesis, hip, femoral component, cemented, metal
  2 reports
• Jet-X 71063026

  BIT, DRILL
  1 report
• Jet-X 71062160

  PIN, FIXATION, THREADED
  1 report
• Jet-X 71062500

  PIN, FIXATION, THREADED
  1 report
• Jet-X 71062600

  PIN, FIXATION, THREADED
  1 report
• Jet-X 71063251

  PIN, FIXATION, THREADED
  1 report
• Jet-X 71065402

  PIN, FIXATION, THREADED
  1 report
• Jet-X 71065507

  PIN, FIXATION, THREADED
  1 report
• Jet-X 71067327

  APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
  1 report
• Jet-X 71067328

  Plate, fixation, bone
  1 report
• Jet-X 71067374

  APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
  1 report
• Jet-X 71067376

  APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
  1 report
• Jet-X 71067312

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 report

Recent Jet-X adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION SURGERY, ONE (1) JETX 3.5 SHT GRAD STEP DRILL FRACTURED. THE BROKEN PIECE COULD BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750300 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN EXTERNAL FIXATOR PLACEMENT ON (B)(6) 2021 TO STABILIZE A RIGHT ANKLE FRACTURE & DISLOCATION, THE PATIENT REQUIRED FRAME REMOVAL WITH I&D ON (B)(6) 2022 DUE TO INFECTED HARDWARE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 21229911 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN EXTERNAL FIXATOR PLACEMENT TO TREAT A FRACTURE OF UPPER END OF LEFT TIBIA PERFORMED ON (B)(6) 2017, THE PATIENT REQUIRED A SUBSEQUENT REMOVAL OF THE EXTERNAL FIXATOR WITH TIBIAL REPAIR WITH INTRAMEDULLARY NAIL DUE TO NONUNION ON (B)(6) 2018. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21229864 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A MULTIPLANAR EXTERNAL FIXATOR PLACEMENT WITH I&D PERFORMED ON (B)(6) 2018 TO TREAT A TIBIAL SHAFT FRACTURE, THE PATIENT REQUIRED A SUBSEQUENT REMOVAL OF THE EXTERNAL FIXATOR ON (B)(6) 2018 DUE TO FRACTURE NONUNION. THE PATIENT UNDERWENT IMN FIXATION WITH LOCAL GRAFT FOR DEFINITIVE FRACTURE STABILIZATION. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21229810 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN EXTERNAL FIXATOR PLACEMENT &ORIF PERFORMED ON (B)(6) 2019 TO TREAT A LEFT ANKLE FRACTURE, THE PATIENT REQUIRED A SUBSEQUENT REMOVAL OF THE EXTERNAL FIXATOR WITH I&D ON 15-OCT-2019 DUE TO PROXIMAL TIBIAL PIN SITE DRAINAGE OF SEROSANGUINEOUS AND MILDLY PURULENT FLUID. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 21229758 ↗
• MalfunctionJan 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING UNILATERAL EXTERNAL FIXATION SURGERY, ONE (1) A/O T-HANDLE CONN W/10MM SOCKET WAS PRESSED TOO HARD UNTIL IT STUCK AND THEN HITTING IT WITH A MALLET BROKE IT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112980 ↗
• InjuryAug 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EX-FIX FOR 2 DAYS PRIOR TO DEFINITIVE FIXATION WITH PLATES & SCREWS ON (B)(6) 2017. THE PATIENT HAD THE SAME EX-FIX REASSEMBLED AT DEFINITIVE FIX SURGERY TO PROVIDE MORE STABILITY & DUE TO POSTEROLATERAL CORNER INJURY. AT 1ST POSTOP CLINIC VISIT ON (B)(6) 2017, PIN SITES WERE NOTICED TO HAVE MIN THICK YELLOW DRAINAGE. CLINDAMYCIN WAS PRESCRIBED DURING 10 DAYS. THE JET-X SYSTEM WAS INITIALLY APPLIED TO TREAT A TIBIAL FRACTURE AND IT WAS REMOVED AT POST OPERATIVE DAY 56 BECAUSE THE FRACTURE WAS ALREADY HEALED. THIS INFORMATION WAS PROVIDED AS PART OF A MULTIDEVICE DATA COLLECTION ACTIVITY ASSOCIATED TO THE JET-X PMCF STUDY, THEREFORE, NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 20059011 ↗
• InjuryAug 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PIN TRACT INFECTION IN ALL 4 INSERTION SITES AFTER BEING TREATED WITH THE APPLICATION OF A JET-X SYSTEM FOR A LEFT SUPRACONDYLAR FEMUR FRACTURE ON (B)(6) 2016. THESE PINS, ALONG WITH THE EXTERNAL FIXATOR, WHERE REMOVED ON (B)(6) 2016. A SHARP DEBRIDEMENT OF ALL OBVIOUS INFECTED SKIN, SUBCUTANEOUS TISSUE AND BONE WAS PERFORMED. THIS INFORMATION WAS PROVIDED AS PART OF A MULTIDEVICE DATA COLLECTION ACTIVITY ASSOCIATED TO THE JET-X PMCF STUDY, THEREFORE, NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 20059009 ↗
• MalfunctionJul 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN EXTERNAL FIXATION SURGERY, ONE (1) JETX 3.5 SHT GRAD STEP DRILL FRACTURED. THE PIECE WAS RETRIEVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19856049 ↗
• MalfunctionJul 20, 2022Material Fragmentation; Dent in Material; Material Fragmentation; Dent in Material

  IT WAS REPORTED THAT THE 5MM/6MM TISSUE PROTCTR FOR LG HALF PIN SLEEVE HAVE DENTS AND CHIPS. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071013 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PIN SHIFTED AND RESULTED IN MIDSHAFT FEMUR FRACTURE 68 DAYS AFTER THE APPLICATION OF A JET-X SYSTEM TO TREAT AN INITIAL OPENED AND CLOSED FRACTURE OF THE TIBIA. THE ISSUE WAS RESOLVED BY AN UNPLANNED REMOVAL OF THE FIXATION SYSTEM. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED AS PART OF A MULTI-DEVICE DATA COLLECTION ACTIVITY ASSOCIATED TO THE JET-X PMCF STUDY, THEREFORE, NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 15070322 ↗
• MalfunctionJun 9, 2022Break; Mechanics Altered; Break; Mechanics Altered

  IT WAS REPORTED THAT THE SIDE OF TIGHTENING OF THE 8MM RATCHET WRENCH IS BROKEN, IT DOESN´T TIGHTEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644846 ↗
• MalfunctionApr 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE CLAMP WAS CHIPPED UPON CLAMPING TO THE 10.5MM BAR. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13982985 ↗
• MalfunctionMar 20, 2022Break; Break

  IT WAS REPORTED THAT, AN 8MM RATCHET WRENCH WAS BREAKING AND NOT WORKING PROPERLY AND NEEDS TO BE REPLACED. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831434 ↗
• MalfunctionFeb 17, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A JET-X 10MM RATCHET WRENCH WAS OBSERVED TO BE BROKEN AND TO NO LONGER WORK DUE TO WEAR AND TEAR. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549229 ↗

Other Smith & Nephew, Inc. products

• FAST-FIX18 models · 9,554 reports
• JOURNEY566 models · 6,250 reports · 4 recalls
• GENESIS II462 models · 4,599 reports · 2 recalls
• DYONICS, POWERMAX, ELITE2 models · 4,308 reports
• TRIGEN381 models · 3,599 reports · 5 recalls
• LEGION446 models · 2,039 reports · 4 recalls
• REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
• Coblation62 models · 2,126 reports