NA 314.746SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982189080), received between Feb 9, 2018 and Nov 25, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

18 other recalls cover devices cleared under the same FDA submission (K013527, K042899, K111437); 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.

Recalls naming this device

1. Jan 24, 2024Open, Classified

   Products not sterilized, sterility cannot be confirmed

   Z-1237-2024 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionNov 25, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR ANKLE RECONSTRUCTION SURGERY. DURING THE SURGERY, IT WAS FOUND THAT THE REAMER HEAD HAD SHEERED OFF AT THE CONNECTION TO THE DRIVE SHAFT AND RIA TUBE ASSEMBLY. THE REAMER HEAD WAS RETAINED INSIDE THE FEMUR. THE PLASTIC TUBING ON THE RIA TUBE ASSEMBLY WAS ALSO FOUND TO BE DISTORTED AND RUPTURED. THE RIA DRIVE SHAFT CANNOT BE DISCONNECTED FROM THE TUBE ASSEMBLY. ALL FRAGMENTS THAT THE SURGEON WAS ABLE TO EXTRACT FROM THE FEMUR WERE EXTRACTED. THERE ARE UNKNOWN VISIBLE ARTIFACTS ON THE X-RAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15-MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED. UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QTY 2); UNKNOWN SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QTY 6). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) RIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12875760 ↗
• MalfunctionNov 10, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHILE PERFORMING THE RIA PORTION, THE TUBE ASSEMBLY BECAME CLOGGED AND WOULD NOT ALLOW THE FLOW OF THE BONE GRAFT. WHILE ATTEMPTED TO DISASSEMBLE THE DRIVESHAFT FROM THE TUBE ASSEMBLY, AND IT WAS LODGED INSIDE OF THE TUBE ASSEMBLY. THE DRIVESHAFT WAS SOMEWHAT DAMAGED WHILE TRYING TO REMOVE IT FROM THE TUBE ASSEMBLY. THE RIA TUBE ASSEMBLY WAS CLOGGED, AND THE DRIVE SHAFT BECAME LODGED INSIDE OF THE ASSEMBLY TUBE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 10 MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: 2.4MM CORTEX (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) UNK - SCREWS: LOCKING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787767 ↗
• MalfunctionMay 5, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF NON-SYNTHES ANTIBIOTIC TIBIA NAIL. DURING THE PROCEDURE, THE REAMER/IRRIGATOR/ASPIRATOR (RIA) ASSEMBLY GOT STUCK ON THE SUPRAPATELLAR SLEEVE ASSEMBLY. THE SURGEON PULLED AGGRESSIVELY, AND THE REAMER HEAD BECAME DETACHED FROM THE RIA TUBE ASSEMBLY. THE RIA REAMER HEAD WAS EASILY RETRIEVED BY PULLING OUT THE REAMING WIRE AND A SECTION OF PLASTIC WAS SHEARED OFF THE RIA TUBE ASSEMBLY, WHICH WAS FOUND INSIDE THE SUPRAPATELLAR SLEEVE. THE PROCEDURE SUCCESSFULLY COMPLETED WITH A FIFTEEN (15) MINUTE DELAY. THE PATIENT HAD AN INFECTION. THIS REPORT IS FOR A RIA TUBE ASSEMBLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776822 ↗
• MalfunctionMay 27, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 WHILE USING THE REAMER IRRIGATOR ASPIRATOR (RIA), THE TUBE ASSEMBLY MALFUNCTIONED AND THE HUB OF METAL SUBSIDED INSIDE OF THE PLASTIC TUBE. THE TIP WAS DAMAGED AS THE SURGEON TRIED TO PULL IT OUT OF THE PLASTIC. A NEW TUBE ASSEMBLY AND THE REAMER HEAD WERE OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 5 MINUTE SURGICAL DELAY WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR 1 RIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092091 ↗
• MalfunctionApr 4, 2018Break; Break

  IT WAS REPORTED THAT A DURING A REAMER/IRRIGATOR/ASPIRATOR (RIA) BONE GRAFT HARVEST PROCEDURE ON (B)(6) 2018 A RIA DRIVE SHAFT 360MM AND A RIA TUBE ASSEMBLY 520MM BROKE IN HALF. THE RIA BONE GRAFT HARVEST WAS THE SECOND STAGE OF A PLANNED AUGMENTATION OF VARIABLE ANGLE (VA) CONDYLAR DISTAL FEMUR FIXATION. THE FIRST PROCEDURE REQUIRED REMOVAL OF ANTIBIOTIC CEMENT TO FILL BONE VOID OF A DISTAL FEMUR DEFECT. THE RIA DRIVE SHAFT 360MM AND THE RIA TUBE ASSEMBLY 520MM WERE ASSEMBLED TOGETHER AND THE SURGEON BEGAN THE FEMUR REAMING PROCESS. HOWEVER, THE RIA WOULD NOT ADVANCE PAST THE FEMORAL ISTHMUS. THE SURGEON REMOVED THE RIA ASSEMBLY FROM THE FEMUR, SUSPECTING THAT THE RIA REAMER HEAD WAS TOO LARGE. WHEN THE SURGEON REMOVED THE ASSEMBLY FROM THE FEMUR IT WAS DISCOVERED THAT THE RIA DRIVE SHAFT 360MM AND THE RIA TUBE ASSEMBLY 520MM WERE BROKEN IN HALF. A SMALL METAL FRAGMENT FELL OFF THE TIP OF THE DRIVE SHAFT, BUT WAS EASILY REMOVED. THE DEVICES WERE TAKEN TO A BACK TABLE WHERE IT WAS DISCOVERED THAT THE WRONG DRIVE SHAFT WAS CONNECTED TO THE TUBE ASSEMBLY (SHORT DRIVE SHAFT 360MM + LONG TUBE ASSEMBLY 520MM). THE SURGERY WAS COMPLETED WITHOUT INCIDENT USING A NEW RIA ASSEMBLY. THERE WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7397808 ↗
• MalfunctionFeb 9, 2018Break; Break

  IT WAS REPORTED WHILE USING THE REAMER IRRIGATOR ASPIRATOR (RIA), THE REAMER DRIVE SHAFT DISENGAGED FROM THE RIA TUBE ASSEMBLY, THE RIA CLIP FELL OFF OF THE ASSEMBLY, THE TIP OF THE RIA DRIVE SHAFT SNAPPED OFF, AND PERFORATED A SMALL HOLE IN THE END OF THE RIA TUBE ASSEMBLY. SURGERY WAS DELAYED APPROXIMATELY 2 MINUTES WHILE A SECOND RIA WAS OPENED AND ASSEMBLED. NO PATIENT CONSEQUENCE WAS REPORTED. INVESTIGATION OF THE RETURNED RIA TUBE ASSEMBLY SHOWED THE DEVICE TO BE BROKEN. THIS REPORT IS FOR ONE (1) RIA TUBE ASSEMBLY. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7259871 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013527, K042899, K111437. One submission often covers many models, so check the product and lot details in each record.

• Z-0578-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
• Z-0586-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
• Z-0577-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
• Z-0571-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
• Z-0587-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
• Z-0580-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
• Z-0584-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
• Z-0585-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
• Z-0579-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
• Z-0583-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
• Z-0573-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
• Z-0581-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
• Z-0582-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
• Z-0572-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
• Z-0575-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S

…and 3 more.