NA 03.010.434Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982068750), received between Oct 6, 2020 and May 26, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K111667); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Break; Material Deformation

  IT WAS REPORTED THAT A VARIETY OF INSTRUMENTS WERE WARPED OR BROKEN. THERE WAS NO REPORTED PATIENT OR USER HARM AND THERE WAS NO DELAY IN SURGERY. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25292223 ↗
• MalfunctionMay 21, 2026Break; Material Deformation

  IT WAS REPORTED THAT THERE WERE MULTIPLE ITEMS THAT WERE WARPED OR BROKEN AT THE FACILITY. THERE WAS NO HARM TO THE PATIENT AND NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241012 ↗
• MalfunctionMar 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON PLAYED WITH THE SUPRAPATELLAR HANDLE AND SLEEVES PRE-OPERATIVELY. THEY NOTED THAT IT WAS DIFFICULT TO SEPARATE THE WIRE GUIDE, PROTECTION SLEEVE, AND HANDLE FROM ONE ANOTHER. WE THEN OPENED ANOTHER SET, AND THEY HAD THE EXACT SAME DIFFICULTIES.

  Patient problems: Insufficient Information

  MAUDE report 21583227 ↗
• MalfunctionMar 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON PLAYED WITH THE SUPRAPATELLAR HANDLE AND SLEEVES PRE-OPERATIVELY. THEY NOTED THAT IT WAS DIFFICULT TO SEPARATE THE WIRE GUIDE, PROTECTION SLEEVE, AND HANDLE FROM ONE ANOTHER. WE THEN OPENED ANOTHER SET, AND THEY HAD THE EXACT SAME DIFFICULTIES.

  Patient problems: Insufficient Information

  MAUDE report 21583213 ↗
• MalfunctionDec 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, THE COMPRESSION DEVICE FOR SUPRAPATELLAR, EXTRACTOR, CONNECTING SCREWS AND EXTRACTION SCREW WERE STRIPPED, TROCARS WERE BENT ALONG WITH THE WIRE GUIDES, BLUE HANDLE, BLACK KNOB BROKE OFF, ALONG WITH BUTTONS ON THE SIDE TO PROTECTION SLEEVE. THE SURGEON WAS AGGRESSIVE AND OVER-TORQUED PRODUCTS LEADING TO STRIPPING AND BENDING OF PRODUCTS. A NEW SET BROUGHT INTO THE ROOM. THERE WERE 10 MINUTES OF SURGICAL DELAY. IT IS UNKNOWN IF THE SURGERY SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) WIRE GUIDE/2 HOLES 14.5/3.2MM FOR SUPRAPATELLAR. THIS REPORT IS 1 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072161 ↗
• MalfunctionOct 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) WIRE GUIDE 12/3.2MM FOR SUPRAPATELLAR, AND ONE (1) WIRE GUIDE 14.5/3.2 FOR SUPRAPATELLAR WERE WORN FROM USAGE, AND NOT UP TO HOSPITAL STANDARDS. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) WIRE GUIDE/2 HOLES 14.5/3.2MM FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10635674 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111667. One submission often covers many models, so check the product and lot details in each record.

• Z-0404-2014 · Oct 14, 2013 · Terminated
  Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabil