NA 03.010.502Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982069191), received between Sep 20, 2022 and Aug 10, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K033618); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Break; Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50192480 ↗
• MalfunctionSep 12, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT INSERTION HANDLE AND PROTECTION SLEEVE WERE BROKEN. INSIDE OF HANDLE IS STRIPPED AND PROTECTION SLEEVE INSERTION PART IS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036307 ↗
• MalfunctionAug 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SLEEVES DO NO FIT IN HANDLES AND GET STUCK. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737620 ↗
• MalfunctionJul 14, 2025Material Integrity Problem; Material Integrity Problem

  THE PRODUCT DAMAGE DOCUMENTED HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500346 ↗
• MalfunctionMay 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TWO INSTRUMENTS WERE DAMAGED THAT WERE ALREADY PRESENT BEFORE THE PROCEDURE. IT'S ABOUT THE CONNECTION BETWEEN THE TWO INSTRUMENTS. THEY FACED ISSUES SINCE THE HANDLE AND THE DRILL SLEEVE COULDN'T BE MOUNTED CORRECTLY ANYMORE. THE PROCEDURE WAS STILL CARRIED OUT, AND THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105373 ↗
• MalfunctionMar 14, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT TWO PARTS AND THE RETRO GRADE FEMORAL NAIL SET BROKE . THE SCRUB TECH PLACED THE PROTECTION SLEEVE ONTO THE TORQUE LIMITING HANDLE. FROM THERE IT COULD NOT BE REMOVED. THIS WAS DONE PRE-OP DURING BACK TABLE SET UP. THERE WAS NO PATIENT INVOLVEMENT. THE SURGERY WENT WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610317 ↗
• MalfunctionNov 19, 2024Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE WIRE BENT IN MULTI GUIDE FROM PRESSURE SO WIRE DOESN¿T SLIDE SMOOTHLY ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723363 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER SURGERY, THE TWO SCREWS GOT STUCK IN THE COUPLING HANDLE AND CANNOT BE PICKED OUT OR REMOVED. NO PATIENT WAS INVOLVED. THIS REPORT IS FOR ONE (1) 13.0 PROTECTION SLEEVE FOR RAFN RETRO/QC. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036365 ↗
• MalfunctionJul 17, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED DURING AN IN-SERVICE WITH HOSPITAL STAFF ON JUNE 21, 2024, THE TWO PIECES WERE SOMEHOW JAMMED/STUCK TOGETHER, RENDERING THEM UNABLE TO BE PROPERLY PLACED INTO THE SETS. APPARENTLY ONE OF THE SURGICAL TECHNICIANS WAS TRYING TO PUT THE INSTRUMENTS TOGETHER BUT FORCED THESE TWO PIECES (THAT DO NOT GO TOGETHER) INSIDE ONE ANOTHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE 13.0 PROTECTION SLEEVE FOR RAFN RETRO/QC THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761068 ↗
• MalfunctionMay 9, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A CASE, BLUE SOFT TISSUE GUIDE WAS BENT AND NO LONGER FUNCTIONAL. IT CAME THROUGH WASH AND WAS NO LONGER IN THE SET. THERE WAS PATIENT INVOLVEMENT AND STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 13.0 PROTECTION SLEEVE FOR RAFN RETRO/QC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280027 ↗
• MalfunctionMar 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON FEBRUARY 23 2024. IT WAS REPORTED THAT THE INSTRUMENTS WERE STUCK TOGETHER AND COULD NOT BE PULLED APART. THIS OCCURRED PRE-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 13.0 PROTECTION SLEEVE FOR RAFN RETRO/QC. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886231 ↗
• MalfunctionMar 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BELGIUM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE DEVICE WAS DEFECTIVE. THE ITEM WAS DAMAGED IN SUCH A WAY THAT IT COULD NOT BE CONNECTED TO THE HANDLE. THIS REPORT INVOLVES ONE (1) 13.0MM PROTECTION SLEEVE FOR RAFN RETROGRADE/QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847263 ↗
• MalfunctionNov 2, 2023Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TWO DEVICES LISTED WERE INCORRECTLY CONNECTED BY THE SCRUB TECH AND ARE NOW STUCK TOGETHER AND COULD NOT BE SEPARATED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 13.0 PROTECTION SLEEVE FOR RAFN RETRO/QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054733 ↗
• MalfunctionJul 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN DATE, THE HANDLE BECAME STUCK, AND THE INSTRUMENT WILL NOT COME APART. THE INSTRUMENT CANNOT BE STERILIZED BECAUSE IT IS STUCK. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 13.0MM PROTECTION SLEEVE FOR RAFN RETROGRADE/QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379887 ↗
• MalfunctionFeb 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE 13MM SLEEVE DID NOT FULLY ENGAGE INTO THE BLUE HANDLE. A LARGE AO CONNECT KEPT DISENGAGING THE REAMER SHAFT, UPON OPENING ANOTHER ONE, IT COULD NOT DISENGAGED FROM THE REAMER SHAFT UNTIL HIT WITH MALLET. THERE WAS A 3 MINUTES SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 13.0 PROTECTION SLEEVE FOR RAFN RETRO/QC. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455968 ↗
• MalfunctionJan 20, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, A NAIL PLATE COMBO WAS BEING IMPLANTED ON A POLY TRAUMA PATIENT. RFNA WAS CONNECTED AND INSERTED WITH A TOTAL KNEE PROSTHESIS IN. WHILE HAVING THE NAIL FULLY INSERTED, THE LM DRILL HOLES MISSED THE NAIL. DEPTH GAUGE WAS INSERTED AND BENT DUE TO MALLETING OF DEPTH GAUGE. PLATE WAS PUT ON THE AIMING ARM AND THE FIXED ANGLE SCREW DID NOT LOCK. A NEW PLATE WAS USED AND THE PLATE LOCKED. THE 13MM SLEEVE WAS BENT DURING THE CASE AS WELL FROM PUSHING AND THE ENTRY REAMER WAS STUCK IN THE SLEEVE. SCREW RACKS HAD FADED NUMBERS & SCREWDRIVER HANDLES DID NOT ATTACH TO THE POWER SHAFT ANY LONGER AND WOULD STAY ON WITHOUT FALLING OFF. POST OP REVIEW SHOWED THAT THE GRAPHIC SCREW RACKS WERE FADED AND CHIPPING, AND THAT THE HANDLES AND SLEEVES WERE NOT ATTACHED/WERE BENT. THE PLATE WAS DROPPED POST OP AND BENT/DEPTH GAUGES BENT. THIS REPORT IS FOR A 13.0MM PROTECTION SLEEVE FOR RAFN RETROGRADE/QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215540 ↗
• MalfunctionDec 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE RFNA NAILS HAD SCREW BACKOUT POST OP, THE DRIVE CAP BROKE INSIDE TFNA INSERTION HANDLES, AND THE SLEEVE WAS COLD WELDED IN THE BLUE HANDLE. THERE WERE NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 13.0MM PROTECTION SLEEVE FOR RAFN RETROGRADE/QC. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15919130 ↗
• MalfunctionSep 20, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, WHILE CHECKING THE SET AFTER IT RETURNED TO OFFICE ONE END OF THE INSTRUMENT HAS A BENT TIP WHERE DRILL BIT ENTERS AND THE DRILL BIT CANNOT GO THROUGH THE INSTRUMENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 13.0 PROTECTION SLEEVE FOR RAFN RETRO/QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455356 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.