NA 352.044Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10886982194138), received between Jul 25, 2018 and Jul 27, 2026 — classified as 91 malfunctions.

The most frequently reported specific device problem is “Break” (36 reports).

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 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Material Deformation

  Patient problems: Insufficient Information

  MAUDE report 50033972 ↗
• MalfunctionMay 26, 2026No Apparent Adverse Event

  IT WAS REPORTED THE DEVICE WAS RECEIVED AS A BLIND UNIT. DURING VISUAL EXAMINATION THE DEVICE WAS DETERMINED TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25276000 ↗
• MalfunctionFeb 27, 2026Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026 REAMER SHAFT CONNECTING TINES FOR THE HEAD WERE BENT AND NOT CLIPPING ONTO THE EXCHANGEABLE REAMER HEADS. ELONGATION TUBE SLIDING OFF RULER TOO EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475086 ↗
• MalfunctionFeb 12, 2026Break; Use of Device Problem

  IT WAS REPORTED THAT ONE OF THE TINES ON THE TIP OF THE REAMING SHAFT IS BROKEN OFF AND MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327761 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025 THAT 352.044 WAS BROKEN DURING USE AT THE TIP OF THE SHAFT WHERE THE REAMER SHAFT MEETS THE REAMER HEAD. THIS WAS DURING A TIBIA NAIL INSERTION. THERE ARE NO ALLEGATIONS AGAINST THE TIBIA NAIL ADVANCED SYSTEM. SURGERY WAS NOT DELAYED. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878575 ↗
• MalfunctionDec 12, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE PRONGS AT THE TIP OF THE LONG FLEXIBLE REAMER SHAFT HAD BECOME BENT INWARD. THIS DEFORMATION PREVENTED THE INSTRUMENT FROM SECURELY ACCEPTING MODULAR REAMER HEADS, RENDERING IT NON-FUNCTIONAL. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788533 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 POSTOPERATIVE IT WAS NOTED THAT THE LATCHING MECHANISM ON THE REAMING SHAFTS WERE BROKEN. THE REAMING HEADS DO NOT LATCH ONTO THE REAMING SHAFT NOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485525 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 POSTOPERATIVE IT WAS NOTED THAT THE LATCHING MECHANISM ON THE REAMING SHAFTS WERE BROKEN. THE REAMING HEADS DO NOT LATCH ONTO THE REAMING SHAFT NOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485501 ↗
• MalfunctionOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER SET WOULD NOT CLICK ONTO THE REAMER SHAFT, IT APPEARED DAMAGED. THE REAMER PAN ITSELF AS WELL AS THE OTHER REAMER PANS (QUANTITY OF 3) WERE PEELING AND COULD NO LONGER BE PROPERLY STERILIZED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389864 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  DURING REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THE FLEXIBLE REAMER WAS BENT OUT OF SHAPE AT TOO MUCH OF AN ANGLE TO BE USABLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346843 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. TWO TIPS OF THE PIECE WERE BROKEN. ANOTHER DEVICE WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038266 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON APRIL 24, 2025. TWO TIPS OF THE PIECE WERE BROKEN. ANOTHER DEVICE WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038265 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. TWO TIPS OF THE PIECE WERE BROKEN. ANOTHER DEVICE WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038261 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE FLEXIBLE REAMER SHAFT SNAPPED DURING REAMING FOR TIBIAL NAIL. REAMER SHAFT BROKE INTO TWO PIECES. THE USER OPENED 2ND SET. SURGERY WAS DELAYED BY 5 MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN.

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

  MAUDE report 21893423 ↗
• MalfunctionMar 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCT IN QUESTION. IN THE SURGERY, THE PRODUCT WAS VERY HARD TO REMOVE, AND EVEN WITH THE SPECIAL TOOL, THE NURSE WAS UNABLE TO REMOVE IT. A DOCTOR MANAGED TO REMOVE IT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597652 ↗
• MalfunctionFeb 18, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING AND STERILIZATION PROCESS, THE TIP OF THE FLEXIBLE REAMING SHAFT WAS BROKEN AND WOULD NOT ACCEPT THE REAMER HEADS.

  Patient problems: Insufficient Information

  MAUDE report 21401346 ↗
• MalfunctionJan 14, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 , THERE WERE BROKEN OR DAMAGED EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149416 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THE REAMER HEADS ARE NOT STICKING TO SHAFTS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621787 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THE REAMER HEADS ARE NOT STICKING TO SHAFTS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621320 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THE REAMER HEADS ARE NOT STICKING TO SHAFTS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621053 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THE REAMER HEADS ARE NOT STICKING TO SHAFTS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620594 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THE REAMER HEADS ARE NOT STICKING TO SHAFTS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620088 ↗
• MalfunctionNov 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585903 ↗
• MalfunctionAug 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, A STRIKE PLATE PIN OUT OF TIBIAL NAIL ADVANCED FELL OUT MAKING THE STRIKE PLATE UNABLE TO DETACH. ALSO, THE SPRING WAS FLOPPING AROUND. THE SURGERY PROCEEDED AS NORMAL AND NO INJURY OCCURRED. THE SMALL PIN OUT OF THE STRIKE PLATE WAS LOCATED, UNFORTUNATELY IT WAS DISCARDED DURING THE DECONTAMINATION PROCESS. ADDITIONALLY, THE LONG REAMER SHAFT WOULD NOT FIT A REAMER HEAD AND WAS TIGHT THROUGH THE REAMING ROD. SWITCHED TO STANDARD REAMING SHAFT AND SURGERY PROCEEDED AS NORMAL. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE SHAFT 620MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968330 ↗
• MalfunctionJun 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE CANNULATED T15 WAS DAMAGED AND CAUSED A SCREW TO STRIP AND DURING REAMING FOR A TIBIAL NAIL THE 5.0 FLEXIBLE REAMER SHAFT WOULD NOT HOLD ONTO THE AO REAMER ATTACHMENT FOR A COMPETITOR'S POWER. STAFF HAD OPENED A SECOND POWER TRAY TO ENSURE IT WASN'T A COMPETITOR ATTACHMENT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT STATUS/ OUTCOME / CONSEQUENCES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) 5.0MM FLEXIBLE SHAFT 620MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19560212 ↗