SPATIAL FRAME 71070720Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010443892), received between Nov 16, 2020 and Feb 10, 2022 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

19 other recalls cover devices cleared under the same FDA submission (K994143); they may or may not involve this specific model.

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

Recent adverse event reports

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

• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TAYLOR FIXATION SURGERY, THE FAST FX STRUT FOR TSF MED BROKE WHILE TIGHTENING. ALL THE BROKEN PIECES WERE RETRIEVED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505700 ↗
• MalfunctionNov 25, 2021Break; Break

  IT WAS REPORTED THAT, THE SHOULDER BOLTS OF A FAST FX STRUT FOR TSF MED AND FAST FX STRUT FOR TSF SHT WERE TIGHTENED BY HAND AND COULD THEN ONLY BE RELEASED WITH A WRENCH. BOTH THREADS WERE BROKEN AS A RESULT. THE SHOULDER BOLT ON THE FAST FX STRUT FOR TSF MED EVEN BROKE OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874512 ↗
• MalfunctionJun 8, 2021Corroded; Physical Resistance/Sticking; Corroded; Physical Resistance/Sticking

  IT WAS REPORTED THAT SEVEN FAST FX STRUT FOR TSF LNG HAD BEEN WASHED TOO MANY TIMES AND WERE STICKING. THIS WAS NOTICED AFTER SURGERY; THEREFORE, THE PATIENT WAS NO LONGER INVOLVED AT THAT MOMENT. AFTER PRODUCT EVALUATION IT WAS FOUND THAT THE STRUT ON THE DEVICE HAS RUST ON IT WHICH IS CAUSING IT TO STICK, RENDERING IT INOPERABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962707 ↗
• MalfunctionMay 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE BOLTS OF THREE FAST FX STRUT FOR TSF MED BROKE WHILE TRYING TO TIGHTEN THE STRUTS BY USING THE WRENCH (OUTSIDE THE PATIENT). THERE WERE NO DELAYS AND THE PROCEDURE WAS FINISHED WITH SMITH AND NEPHEW BACK UP DEVICES. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825906 ↗
• MalfunctionMay 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE BOLTS OF THREE FAST FX STRUT FOR TSF MED BROKE WHILE TRYING TO TIGHTEN THE STRUTS BY USING THE WRENCH (OUTSIDE THE PATIENT). THERE WERE NO DELAYS AND THE PROCEDURE WAS FINISHED WITH SMITH AND NEPHEW BACK UP DEVICES. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825869 ↗
• MalfunctionMay 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE BOLTS OF THREE FAST FX STRUT FOR TSF MED BROKE WHILE TRYING TO TIGHTEN THE STRUTS BY USING THE WRENCH (OUTSIDE THE PATIENT). THERE WERE NO DELAYS AND THE PROCEDURE WAS FINISHED WITH SMITH AND NEPHEW BACK UP DEVICES. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825829 ↗
• MalfunctionMay 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE, WHEN GOING TO ATTACH THE FAST FX STRUT FOR TSF MED OF THE TAYLOR SPATIAL FRAME, IT WAS FOUND OUT THAT THE STRUTS ARE CROSS THREADED AND COULD NOT BE LENGTHENING. INSTRUMENT OUTSIDE THE PATIENT. 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 11810114 ↗
• MalfunctionMay 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE, WHEN GOING TO ATTACH THE FAST FX STRUT FOR TSF MED OF THE TAYLOR SPATIAL FRAME, IT WAS FOUND OUT THAT THE STRUTS ARE CROSS THREADED AND COULD NOT BE LENGTHENING. INSTRUMENT OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810102 ↗
• InjuryMay 6, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A CORRECTION OF A TIBIA DEFORMITY IN A PATIENT, AFTER IMPLANTATION OF A TSF EXTERNAL FIXATION SYSTEM; THERE WAS A VARUS/ROTATIONAL/LENGTH CORRECTION BEING DONE, AND IT WAS NOTICED THAT THE FAST FX STRUT FOR TSF MED DID NOT CORRESPOND TO THE PRESCRIPTION. THIS WAS NOTICED WHEN THE PATIENT CAME BACK INTO CLINIC ALMOST CLOSE TO THE CONSOLIDATION PHASE. THE STRUT WAS NOT LOCKED PROPERLY; DESPITE THE FACT THAT THE STRUT WAS LOCKED DOWN, IT WAS ABLE TO ROTATE, MOVE UP, DOWN AND LENGTHEN OR SHORTEN UNINTENTIONALLY. IN ORDER TO FIX THIS ISSUE, THE PIECE WAS LOCKED MANUALLY USING TAPE IN THE SAME DEVICE. THE DEFORMITY CORRECTION COULD HAVE BEEN A LOT SMOOTHER HAD THIS INCIDENT NOT OCCUR. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781909 ↗
• MalfunctionMay 6, 2021Material Fragmentation; Device Markings/Labelling Problem; Material Deformation; Material Fragmentation; Device Markings/Labelling Problem; Material Deformation

  IT WAS REPORTED THAT (3) FAST FX STRUT FOR TSF {} MED (CASE: (B)(4), CASE: (B)(4), CASE: (B)(4)), (6) FAST FX STRUT X-SHORT (CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4)), (6) FAST FX STRUT FOR TSF {} SHT (CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4)) AND (1) FAST FX STRUT FOR TSF {} LNG (CASE: (B)(4)) ARE LOOSING THE BLACK COATING ON THE OUTSIDE MAKING IMPOSSIBLE TO READ THE NUMBERS. SOME ALSO WILL NOT ALLOW THE SHOULDER BOLTS TO THREAD IN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781887 ↗
• MalfunctionMay 6, 2021Material Fragmentation; Device Markings/Labelling Problem; Material Deformation; Material Fragmentation; Device Markings/Labelling Problem; Material Deformation

  IT WAS REPORTED THAT (3) FAST FX STRUT FOR TSF {} MED (CASE: (B)(4), CASE: (B)(4), CASE: (B)(4)), (6) FAST FX STRUT X-SHORT (CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4)), (6) FAST FX STRUT FOR TSF {} SHT (CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4), CASE: (B)(4) AND (1) FAST FX STRUT FOR TSF {} LNG (CASE: (B)(4)) ARE LOOSING THE BLACK COATING ON THE OUTSIDE MAKING IMPOSSIBLE TO READ THE NUMBERS. SOME ALSO WILL NOT ALLOW THE SHOULDER BOLTS TO THREAD IN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781884 ↗
• MalfunctionMay 4, 2021Material Fragmentation; Device Markings/Labelling Problem; Material Deformation; Material Fragmentation; Device Markings/Labelling Problem; Material Deformation

  IT WAS REPORTED THAT FAST FX STRUT FOR TSF {} MED IS LOOSING THE BLACK COATING ON THE OUTSIDE MAKING IMPOSSIBLE TO READ THE NUMBERS AND WILL NOT ALLOW THE SHOULDER BOLTS TO THREAD IN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772987 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT THE TOP OF THE FAST FX STRUT FOR TSF MED FELL APART WHEN IT WAS BEING ATTACHED TO THE RING. THE PROCEDURE WAS COMPLETED WITH A BACKUP AND WITH NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641292 ↗
• MalfunctionDec 3, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE THREADS DID NOT ACCEPT A SHOULDER BOLT ON ONE END OF THE STRUT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10942594 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED THAT THE FAST FX STRUT FOR TSF MED BROKE OFF PRIOR TO SURGERY. OPERATION WAS STILL ABLE TO MOVE FORWARD WITH AN S&N BACKUP DEVICE WITHOUT ANY DELAY. THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10844460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K994143. One submission often covers many models, so check the product and lot details in each record.

• Z-1759-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71055201, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1749-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71056258, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1756-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 60 MM SHORT HALF PIN TI-6AL-4V, REF 71056608, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1760-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71055251, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1751-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71056358, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1750-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71056308, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1754-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 50 MM SHORT HALF PIN TI-6AL-4V, REF 71056508, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1765-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71055551, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1753-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 45 MM SHORT HALF PIN TI-6AL-4V, REF 71056458, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1757-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 65 MM SHORT HALF PIN TI-6AL-4V, REF 71056658, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1752-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71056408, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1755-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71056558, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1748-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71056208, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1761-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71055301, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1747-2012 · Apr 13, 2012 · Terminated
  JET-X(R) BAR 5 MM X 45 MM BAR SHORT HALF PIN TI-6AL-4V, REF 71055451, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.

…and 4 more.