NA 03.010.430Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982068712), received between Mar 27, 2017 and May 26, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 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 25292116 ↗
• MalfunctionMay 21, 2026Break; Material Deformation

  THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240906 ↗
• 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 21583231 ↗
• 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 21583205 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT ON JAN 12, 2024 THE LACK KNOB ON THE HANDLE BROKEN DURING SURGERY. PRODUCT CAN BE RETURNED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO DEBRIS REMOVAL WAS REQUIRED FROM THE PATIENT. THIS REPORT IS FOR ONE (1) HNDL FOR PROTEC SLVS FOR SUPRAPATELLAR THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595731 ↗
• MalfunctionMar 29, 2023Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility

  IT WAS FURTHER NOTED THE TOP PIECE OF TROCAR IS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639370 ↗
• MalfunctionMar 29, 2023Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility

  IT WAS FURTHER NOTED THE TOP PIECE OF TROCAR IS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639348 ↗
• MalfunctionDec 14, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A HARVESTING KIT WITH RIA ATTACHMENT SHAFT BROKE WHEN TRYING TO REMOVE FROM INSIDE THE TIBIA. THE REAMER HEAD ON THE RIA SHAFT WAS THE 10.0MM REAMER HEAD FOR RIA 2 STERILE. THE PARTS WITH ARTICULAR SHAFT PIECES BROKE, AND ALL PARTS WERE RETRIEVED. THE ASSOCIATED PIECES WERE THE SUPRAPATELLAR DRILL GUIDE (03.010.425), HANDLE (03.010.430), AND OUTER PROTECTION SLEEVE (03.010.437). THIS HANDLE WAS TEND TO BE REAMER (357.399) AS IN THE TECHNIQUE GUIDE; THIS T SHAFT WAS MENTIONED TO BE BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15979896 ↗
• MalfunctionOct 11, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE SURGEONS IN THE PREVIOUS 2 CASES HAVE BEEN COMPLAINING THAT SOMETHING ON THE HANDLE IS NOT THE SAME AS IT HAS PREVIOUSLY BEEN. ON INSPECTION, THE GROOVE TO ATTACH THE STERILE PROTECTION SLEEVE HAS WARPED AND THEREFORE NEEDS TO BE REPLACED TO BE USED IN SURGERIES. THE SURGERY PROLONGED FOR TEN MINUTES DUE TO THE EVENT. THIS REPORT IS FOR ONE (1) HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15582223 ↗
• MalfunctionFeb 25, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE SUPRAPATELLAR BLUE HANDLED WAS OVER TORQUED AND THE GUIDE WAS BENT IN THE PROCESS. THE SURGEON WANTED THE WHOLE ENTIRE CONSTRUCT REPLACED AFTER THE PROCEDURE. ANOTHER SET WAS BROUGHT IN THE ROOM THE COMPENSATE OF THE BENT GUIDE CONSTRUCT. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604254 ↗
• MalfunctionFeb 25, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE SUPRAPATELLAR BLUE HANDLED WAS OVER TORQUED AND THE GUIDE WAS BENT IN THE PROCESS. THE SURGEON WANTED THE WHOLE ENTIRE CONSTRUCT REPLACED AFTER THE PROCEDURE. ANOTHER SET WAS BROUGHT IN THE ROOM THE COMPENSATE OF THE BENT GUIDE CONSTRUCT. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13603158 ↗
• 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 (1) HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120405 ↗
• MalfunctionJan 22, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR WAS NOT FUNCTIONAL BEFORE THE CASE STARTED. THE RETENTION KNOB (BLACK KNOB) ON TOP OF THE HANDLE FOR PROTECTION SLEEVE IS BROKEN AND NOT ABLE TO FUNCTION PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1) HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11219618 ↗
• MalfunctionJan 6, 2020Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION BEFORE A CASE ON (B)(6) 2019, THE BLACK PART OF THE HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR THAT HOLDS THE TROCARS WAS BENT AND WILL NOT HOLD THEM IN. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN TROCAR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9555410 ↗
• MalfunctionMar 27, 2017Mechanical Problem; Mechanical Problem

  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 12 MM 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 DEVICE REPORTED: SUPRAPATELLAR TITANIUM CANNULATED TIBIA NAIL (QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6437205 ↗

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