NA 03.010.435Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982068767), received between Mar 27, 2017 and Sep 28, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Integrity Problem

  Patient problems: Insufficient Information

  MAUDE report 50915986 ↗
• 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 25292025 ↗
• 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 25241167 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT THE SLEEVE EDGE HAD BEEN CHIPPED. THERE WERE NO VISIBLE FRAGMENTS. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872599 ↗
• MalfunctionFeb 26, 2026Material Deformation

  IT WAS REPORTED THAT DEVICE WAS BENT. NO OPERATION INVOLVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454372 ↗
• MalfunctionJan 30, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE PROTECTION SLEEVE WAS BENT IN A WAY THAT DIDN¿T ALLOW THE INSERTS TO SEAT PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221157 ↗
• MalfunctionJan 30, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE PROTECTION SLEEVE WAS BENT IN A WAY THAT DIDN¿T ALLOW THE INSERTS TO SEAT PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221120 ↗
• MalfunctionJan 16, 2026Material Deformation

  IT WAS REPORTED THAT TIP OF THE 12.0MM PROTECTION SLEEVE STRAIGHT FOR 8MM-11MM NAILS WAS DENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094983 ↗
• MalfunctionDec 29, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025 THE END OF THE DEVICE IS KINKED, DENTED, AND CHEWED UP. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905497 ↗
• MalfunctionOct 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF SURGERY FOR TIBIAL SHAFT FRACTURES. THE SURGERY WAS PERFORMED USING TNA AND STARTED WITH STANDARD TECHNIQUES USING A SUPRAPATELLAR APPROACH. A SOLID PROTECTION SLEEVE WAS USED, AND THE MEDULLARY CANAL REAMER PROCEDURE WAS PERFORMED. THE NAIL WAS THEN INSERTED WITHOUT REMOVING THE METAL PROTECTION SLEEVE. THE NAIL WAS ADVANCED TO THE DISTAL TIBIA ONCE, BUT IT WAS REMOVED TO RESTART THE REAMING PROCEDURE. WHEN REMOVING THE NAIL, IT BECAME STUCK IN THE PROTECTION SLEEVE, AND IT WAS DETERMINED THAT IT WOULD BE IMPOSSIBLE TO DETACH THE NAIL FROM THE SLEEVE DURING SURGERY, SO ONE SIZE SHORTER NAIL WAS INSERTED INSTEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES¿ DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351852 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025, THE TIP OF METAL TROCAR BROKE OFF AND BECAME UNUSABLE IN A SAFE MANNER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212029 ↗
• MalfunctionJun 4, 2025Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT THE BOTTOM OF DEVICE IS PITTED/CHIPPED. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142246 ↗
• MalfunctionApr 28, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON APR 3, 2025, OUTER SLEEVE OF EX SUPRA PATELLAR SLEEVE DAMAGED TO THE POINT WHERE THE INNER TRACER CAN'T PASS THROUGH. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 21920425 ↗
• 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 21583237 ↗
• 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 21583214 ↗
• MalfunctionDec 4, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON OCTOBER 24, 2023, THAT 1 ISSUE WAS FOUND WHEN PROCESSING TRAYS. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) 12.0 PROTECTION SLV STR FOR 8-11 NAILS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256522 ↗
• MalfunctionApr 4, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, NEITHER THE PLASTIC TROCAR OR THE WIRE SLEEVE WOULD FIT INSIDE THE OUTER METAL SLEEVE. HOWEVER, THE METAL SLEEVES AND TROCAR WOULD FIT INSIDE A DIFFERENT SLEEVE FROM ANOTHER SET. SO IT¿S DETERMINED THE ONLY THING WRONG HERE IS THE OUTER SLEEVE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 12.0MM PROTECTION SLV STRAIGHT FOR 8MM-11MM NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674011 ↗
• 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) 12.0MM PROTECTION SLV STRAIGHT FOR 8MM-11MM NAILS. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120348 ↗
• MalfunctionJul 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, WHILE REAMING A SUPRAPATELLAR TIBIAL NAIL, THERE WAS DIFFICULTY TO CATCHING THE FLEXIBLE REAMERS ON THE PROTECTION SLEEVE WHEN RETRACTING FLEXIBLE REAMER. FURTHERMORE, WHEN DRILLING FOR THE S1 PROXIMAL INTERLOCKING SCREW, THE DRILL BIT WOULD NOT PASS THROUGH THE NAIL AND UNABLE TO PLACE A SCREW THROUGH THE DESIRED HOLE. THE S2 PROXIMAL INTERLOCKING SCREW WAS SUCCESSFULLY DRILLED AND INSERTED ALONG WITH ANOTHER PROXIMAL OBLIQUE SCREW. THERE WAS 10 MINUTES OF SURGICAL DELAY NOTED. NO FRAGMENTS GENERATED NOTED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNK - INSERTION INSTRUMENTS: TRAUMA :PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). UNK - REAMING RODS :PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) PROTECT SLEEVE 12 F/ETN F/SUPRAPATELLAR. THIS REPORT IS 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188894 ↗
• 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 11 DEVICES. THIS REPORT IS FOR (1) 12.0MM PROTECTION SLV STRAIGHT FOR 8MM-11MM NAILS. THIS REPORT IS 6 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072170 ↗
• MalfunctionFeb 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AN UNKNOWN INNER PROTECTION SLEEVE FOR SUPRAPATELLAR INSTRUMENT WAS STICKING. THERE WAS DIFFICULTY INSERTING THE CENTERING SLEEVE AND INSERTING AN UNKNOWN GUIDE WIRE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE SUCCESSFULLY COMPLETE. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE: UNK - GUIDE/COMPRESSION/K-WIRES: TRAUMA. THIS REPORT IS FOR ONE 12.0MM PROTECTION SLV STRAIGHT FOR 8MM-11MM NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673417 ↗
• MalfunctionMar 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, DURING A TIBIAL NAILING PROCEDURE, THE EXPERT TIBIAL NAIL (ETN) GOT STUCK IN THE PROTECTION SLEEVE WHILE PASSING THROUGH THE TROCAR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT THE AID OF THE TROCAR. THERE WAS NO SURGICAL DELAY. IT WAS NOTED THE PATIENT/SURGICAL OUTCOME WAS AS PLANNED. THIS REPORT IS FOR A PROTECTION SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8459854 ↗
• MalfunctionAug 21, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SUPRAPATELLAR TIBIAL NAIL PROCEDURE ON (B)(6) 2018, THE TIP OF A DRIVING CAP BROKE WHILE DRIVING THE NAIL. THIS OCCURRED OUTSIDE OF THE PATIENT, AND NO ACTION WAS NEEDED TO REMOVE THE FRAGMENT FROM THE PATIENT. THE PROTECTION SLEEVE, STRAIGHT, WAS ALSO BENT WHILE REINSERTING THE NAIL. A SECOND SET OF INSTRUMENTS WAS OPENED DUE TO THE DEVICE ISSUES. THERE WAS A 2 MINUTE SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE: TIBIAL NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), HAMMER (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 12.0MM PROTECTION SLEEVE STRAIGHT FOR 8MM-11MM NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7800636 ↗
• MalfunctionMar 27, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR A TIBIA FRACTURE (SIDE UNKNOWN) ON (B)(6) 2017. DURING THE PROCEDURE WHILE THE SURGEON WAS TREATING THE PATIENT WITH A SUPRAPATELLAR TIBIA NAIL AND UPON EXCHANGE OF THE 12MM PROTECTION SLEEVE; THE SLEEVE WOULD NOT RELEASE FROM THE SUPRAPATELLAR HANDLE EFFECTIVELY. THE SURGEON EVENTUALLY WAS ABLE TO RELEASE THE SLEEVE FROM THE HANDLE BY MANUALLY PULLING THE SLEEVE FROM THE HANDLE WITH A PAIR OF PLIERS. THE SURGEON WAS UNSURE AS TO WHICH DEVICE WAS DEFECTIVE OR POSSIBLY BOTH. THERE WAS A SURGICAL TIME DELAY OF APPROXIMATELY TWENTY TO THIRTY (20-30) SECONDS. THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION AND NO X-RAYS. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT STATUS OUTCOME IS FINE. CONCOMITANT MEDICAL PRODUCTS: SUPRAPATELLAR TITANIUM CANNULATED TIBIA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6437154 ↗

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