ATTUNE 2545-00-047Recalls & reported problems
Depuy (Ireland) · ATTUNE SAW CAPTURE SIZE 9-10 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE saw capture is a plastic attachment used to hold a surgical saw blade onto a bone cutting block during orthopedic surgery. The 30 reports mostly describe the red plastic clip or latch breaking, cracking or coming apart, sometimes while the surgeon was applying it, and one describes it sliding off and no longer gripping. No deaths or injuries are mentioned, and most reports note no effect on the patient. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295130543), received between Jul 28, 2017 and Apr 23, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Break” (26 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
- Break26
- Device-Device Incompatibility5
- Crack1
- Detachment of Device or Device Component1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient8
- Insufficient Information3
- No Information2
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Break
IT WAS REPORTED THAT THE RED PLASTIC CLIP WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967075 ↗MalfunctionApr 13, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIECE WON'T CLAMP DOWN, THE PLASTIC WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859797 ↗MalfunctionJan 21, 2026Break
IT WAS REPORTED THAT WHILE THE SURGEON APPLIED THE POSTERIOR SAW CAPTURE TO THE BLOCK PINNED TO THE DISTAL FEMUR, THE CAPTURE¿S RED MODULAR COMPONENT BROKE DURING APPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24134503 ↗MalfunctionOct 20, 2025Break; Break
IT WAS REPORTED THAT BROKEN CLIP ON 9/10 SAW CAPTURE ATTUNE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23336683 ↗MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE LATCH ON THE SAW CAPTURE WILL NO LONGER ATTACH TO THE FEMUR BLOCK AND SLIDES OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23087059 ↗MalfunctionFeb 6, 2025Break; Break
IT WAS REPORTED THAT THE LATCH WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 21322863 ↗MalfunctionOct 3, 2024Break; Break
IT WAS REPORTED THAT A PIECE OF THE PLASTIC FROM RED BUTTON ON OUR POSTERIOR CAPTURE FOR THE FOUR IN ONE CUTTING BLOCK BROKE OFF DURING A CASE.
Patient problems: Insufficient Information
MAUDE report 20358606 ↗MalfunctionAug 21, 2024Break; Break
IT WAS REPORTED THAT THE SAW CAPTURE SZ 9-10 LATCH BROKE AND THE SPRING CAPTURE BENT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20017112 ↗MalfunctionNov 9, 2023Break; Break
ATTUNE MACRO SAW CAPTURE BROKE MID CASE, RED ACTUATOR SNAPPED OFF. FRAGMENTS GENERATED WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18100447 ↗MalfunctionSep 29, 2023Break; Break
IT WAS REPORTED THAT THE POSTERIOR CAPTURE 9/10 WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17842771 ↗MalfunctionJul 12, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17313202 ↗MalfunctionJun 20, 2023Break; Break
IT WAS REPORTED THAT THE ATTUNE POSTERIOR CAPTURE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17164128 ↗MalfunctionMar 6, 2023Break; Break
IT WAS REPORTED THAT THE SAW CAPTURE LOCKING MECHANISM WAS BROKEN DURING CASE. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 16485079 ↗MalfunctionDec 1, 2022Break; Break
IT WAS REPORTED THAT THE PART OF RED CLIP BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15895385 ↗MalfunctionMar 10, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
THE SAW CAPTURE WAS NOT ENGAGING WITH THE CUTTING BLOCK. IT APPEARS THAT THE MECHANISM IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13725078 ↗MalfunctionDec 20, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATING, "THE IMPACTOR CRACKED UP NEAR WHERE IT CONNECTS TO THE HANDLE. THE RED CLIP THAT HOLDS THE CAPTURE TO THE BLOCK IS BROKEN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13044854 ↗MalfunctionDec 7, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT TWO FEMORAL INTRODUCERS DURING FINAL IMPLANTATION HAD THE ROTATING KNOB SNAP OFF DURING IMPLANTATION. AFTER THE BAT HAD SNAPPED THE SECOND TIME IT WAS NO LONGER USED AND SWITCHED TO THE FEMORAL IMPACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12955062 ↗MalfunctionSep 22, 2021Break; Break
IT WAS REPORTED THAT CLIP ON INSTRUMENT BROKE AND WOULD NOT ENGAGED INTO 4-1 BLOCK. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12513418 ↗MalfunctionJul 8, 2021Break; Break
IT WAS REPORTED THAT THE CAPTURE BROKE. WILL NOT STAY ON BLOCK
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12134473 ↗MalfunctionAug 4, 2020Break; Break
SURGEON BROKE SMALL RED PLASTIC LOCKING TAB ON SAW CAPTURE WHILE CUTTING THE 4-IN-1 BLOCK. ONE SMALL FRAGMENT WAS GENERATED, WHICH WAS LOCATED AND REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10363410 ↗MalfunctionJul 29, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
WAS THERE AN ALLEGED DEVICE DEFICIENCY FOR THE PRODUCTS REPORTED? WOULD NOT STAY CLIPPED IN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8835943 ↗MalfunctionJul 15, 2019Break; Break
IT WAS REPORTED THAT THE RED PLASTIC RELEASE MECHANISM ON THE 9-10 CAPTURE WAS BROKEN. THE LITTLE LIP THAT HOLDS IT TO THE CUTTING BLOCK WAS WHAT BROKE OFF. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8789096 ↗MalfunctionMar 6, 2019Break; Break
IT WAS REPORTED THAT WHILE RESETTING INSTRUMENTS NOTICED THE RED TAB ON THE SIZE 9-10 CAPTURE WAS BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8395233 ↗MalfunctionNov 21, 2018Break; Break
IT WAS REPORTED THAT THE RED TAB BROKE OFF OF THE SAW CAPTURE WHILE USING IT TO PREPARE THE FEMUR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8094176 ↗MalfunctionOct 10, 2018Crack; Crack
PLASTIC IS CRACKED. ALL PIECES RETRIEVED, NO PATIENT CONSEQUENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7954104 ↗
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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