SPATIAL FRAME 71070710Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010474308), received between May 4, 2021 and Nov 25, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION, 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. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874546 ↗
• MalfunctionJun 30, 2021Peeled/Delaminated; Mechanics Altered; Peeled/Delaminated; Mechanics Altered

  IT WAS REPORTED THAT, THE PAINT OF THE FAST FX STRUT FOR TSF SHT WAS CHIPPING AND THE DEVICE WAS NOT EXTENDING PROPERLY. IT IS UNKNOWN WHEN THE EVENT OCCURRED AND IF THERE WAS A PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096835 ↗
• 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 11781923 ↗
• 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 ((B)(4)), (6) FAST FX STRUT X-SHORT ((B)(4)), (6) FAST FX STRUT FOR TSF {} SHT ((B)(4)) AND (1) FAST FX STRUT FOR TSF {} LNG ((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 11781919 ↗
• 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 11781917 ↗
• MalfunctionMay 5, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE FAST FX STRUT FOR TSF SHT IS WEARING NUMBERS OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781319 ↗
• MalfunctionMay 5, 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 11781314 ↗
• MalfunctionMay 4, 2021Material Fragmentation; Device Markings/Labelling Problem; Material Deformation; Material Fragmentation; Device Markings/Labelling Problem; Material Deformation

  IT WAS REPORTED THAT THE FAST FX STRUT FOR TSF {} SHT 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 11772944 ↗
• MalfunctionMay 4, 2021Material Fragmentation; Device Markings/Labelling Problem; Material Deformation; Material Fragmentation; Device Markings/Labelling Problem; Material Deformation

  IT WAS REPORTED THAT THE FAST FX STRUT FOR TSF {} SHT 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 11772907 ↗

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-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-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-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-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-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-1763-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71055401, 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-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-1758-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 70 MM SHORT HALF PIN TI-6AL-4V, REF 71056708, 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-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-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-1762-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71055351, 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.