NA 03.010.436Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982068774), received between Dec 24, 2020 and May 26, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 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 25292132 ↗
• 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 25241188 ↗
• 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 21583225 ↗
• 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 21583209 ↗
• MalfunctionJan 16, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED ON (B)(6) 2023, THE LITTLE NUB ON THE LONG INSERTION HANDLE THAT ALLOWS THE AIMING ARM TO LATCH ONTO THE LONG INSERTION HAND BROKE. FRAGMENTS WERE GENERATED BUT WERE EASILY REMOVED. THE AIMING ARM WILL NO LONGER ATTACH. THE TIP OF 14.5MM INSERTION SLEEVE IS BENT AND NO LONGER ALLOWS THE TROCAR OR WIRE GUIDE TO FIT INSIDE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH MINIMAL SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 14.5MM PROTECTION SLV STRAIGHT FOR 12MM-13MM NAILS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519983 ↗
• MalfunctionDec 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE THREADS ON THE CANNULATED CONNECTING SCREW APPEAR STRIPPED, MAKING IT DIFFICULT TO REMOVE CONNECT OR DISCONNECT FROM NAIL. PROTECTION SLEEVES WERE JAMMED IN THE PROTECTION SLEEVE HANDLE AND ARE VERY DIFFICULT TO DISASSEMBLE. CONCOMITANT DEVICES REPORTED: UNK - NAILS(PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS REPORT IS FOR ONE (1) 14.5MM PROTECTION SLV STRAIGHT FOR 12MM-13MM NAILS. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120380 ↗
• MalfunctionMar 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE SUPRAPATELLAR SLEEVE SEEMS TO BE DEFECTIVE, WOULD NOT FIT INTO THE PROTECTION SLEEVE. ANOTHER SET WAS GRABBED ON THE SHELF AND THE INNER SLEEVE WOULD FIT JUST FINE THROUGH THE NEW SLEEVE. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS FOR ONE (1) 14.5MM PROTECTION SLV STRAIGHT FOR 12MM-13MM NAILS. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463766 ↗
• MalfunctionDec 24, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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) 14.5MM PROTECTION SLV STRAIGHT FOR 12MM-13MM NAILS THIS REPORT IS 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072168 ↗

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