ATTUNE 2545-00-119Recalls & reported problems
Depuy (Ireland) · ATTUNE BASE PIN · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE base pin is used in orthopedic surgery to help position implants during knee procedures. The reports describe pins and related tools wearing out, bending, cracking, or having stripped threads so they no longer fit into the tibial tray or stay in place, with most problems noticed during processing or surgery and no patient harm described. There are 44 reports, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295130932), received between Mar 9, 2021 and Sep 16, 2026 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Break” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break13
- Naturally Worn13
- Device-Device Incompatibility11
- Material Deformation11
- Detachment of Device or Device Component3
- Scratched Material2
- Failure to Cut1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793788 ↗MalfunctionJun 2, 2026Material Deformation
IT WAS REPORTED THAT ON PINNING OF FEMORAL SULCUS PINS WORN AND WONT PURCHASE. THREADS WERE DAMAGED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360397 ↗MalfunctionJun 2, 2026Material Deformation
IT WAS REPORTED THAT ON PINNING OF FEMORAL SULCUS PINS WORN AND WONT PURCHASE. THREADS WERE DAMAGED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360394 ↗MalfunctionFeb 5, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIAL PIN CAN NO LONGER BE DRILLED PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24269218 ↗MalfunctionSep 15, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT BOTH BASE ATTUNE PINS STRIPPED AND WOULD NOT REMAIN IN THE TIBIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23050943 ↗MalfunctionSep 15, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT BOTH BASE ATTUNE PINS STRIPPED AND WOULD NOT REMAIN IN THE TIBIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23050942 ↗MalfunctionJun 13, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THE PINS BENT, THEREFORE WILL NOT FIT THROUGH TIBIAL TRAY. IT WAS NOTICED DURING SURGERY. NO EFFECT ON PATIENT AS SPARE TRAY AVAILABLE. NO DELAY TO SURGERY. NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202124 ↗MalfunctionMay 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE ATTUNE BASE PINS BENT AND NO LONGER FIT THROUGH TIBIAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22062176 ↗MalfunctionMay 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE ATTUNE BASE PINS BENT AND NO LONGER FIT THROUGH TIBIAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22062147 ↗MalfunctionMay 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE ATTUNE BASE PINS BENT AND NO LONGER FIT THROUGH TIBIAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22062133 ↗MalfunctionMay 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE ATTUNE BASE PINS BENT AND NO LONGER FIT THROUGH TIBIAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22062119 ↗MalfunctionMar 25, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE FEMORAL IMPACTOR BROKE DURING IMPACTION, THE PATIENT DID NOT RETAIN FRAGMENTS. THE BASE PIN WAS DETHREADED WHICH WAS NOTICED IN THE TIBIAL TRAY. THE SULCUS GUIDE WAS NOT FIXATING PROPERLY AND WAS UNUSABLE FOR CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21686938 ↗MalfunctionFeb 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSTRUMENT LOST INSTRUMENTS BY SPD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21357166 ↗MalfunctionFeb 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSTRUMENT LOST INSTRUMENTS BY SPD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21357113 ↗MalfunctionNov 18, 2024Break; Break
IT WAS REPORTED INSTRUMENTS WERE BROKEN ON AN UNKNOWN DATE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20711026 ↗MalfunctionNov 18, 2024Break; Break
IT WAS REPORTED INSTRUMENTS WERE BROKEN ON AN UNKNOWN DATE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20709981 ↗MalfunctionNov 14, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY, AND THE TIBIA PINS WERE CHIPPED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20685638 ↗MalfunctionNov 14, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY, AND THE TIBIA PINS WERE CHIPPED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20685627 ↗MalfunctionOct 14, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A SURGERY VIA TKA FOR OA. THE BASE PIN IN QUESTION WAS USED FOR FIXING A TIBIA BASE PLATE. THE PIN ENTERED AT AN ANGLE BECAUSE THE BONE WAS STIFF AND INTERFERED WITH THE PLATE, RESULTING IN BREAKING OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE BASE PIN WAS DISCARDED AT THE HOSPITAL BECAUSE THIS SURGERY WAS A CASE OF AN INFECTED PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20439413 ↗MalfunctionApr 15, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE THREADS OF THE PIN ARE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19112457 ↗MalfunctionJan 23, 2024Break; Break
IT WAS REPORTED THAT THE TIBIAL PINS WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18563031 ↗MalfunctionJan 23, 2024Break; Break
IT WAS REPORTED THAT THE TIBIAL PINS WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18563007 ↗MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PINS WERE USED AND AFTER THEY CAME OUT OF THE WASH, THESE WERE MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18552634 ↗MalfunctionDec 8, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE FINISH ON THE BASE PIN APPEARED WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18292401 ↗MalfunctionDec 8, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE FINISH ON THE BASE PIN APPEARED WORN,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18292394 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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