P.F.C. 86-9188Recalls & reported problems
Depuy (Ireland) · P.F.C. PATELLAR CALIPER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295218180), received between Aug 10, 2017 and Sep 14, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
- Mechanical Jam2
- Scratched Material2
- Unintended Movement2
- Detachment of Device or Device Component1
- Device Damaged Prior to Use1
- Device-Device Incompatibility1
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient4
- No Information1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763812 ↗MalfunctionMar 20, 2026Structural Problem
IT WAS REPORTED THAT CALIPER WAS NOT LOCKING PROPERLY. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651893 ↗MalfunctionJan 8, 2026Unintended Movement
IT WAS REPORTED THAT DURING KNEE SURGERY AN INSTRUMENT'S SCREW BECAME LOOSE. NOTHING BROKE INTO TWO PIECES. THERE WERE NO DELAYS TO THE PROCEDURE, AND NO PARTS WERE LEFT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24011138 ↗MalfunctionJul 18, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE PRODUCTS WERE EITHER SCRATCHED TOO BADLY OR DULL/WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22544198 ↗MalfunctionMay 1, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED. STATING, THAT THERE WAS NO SURGICAL DELAY. AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19220856 ↗MalfunctionNov 9, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE LOCKING SCREW UP ON CALIPER WAS TOO TIGHT AND CANNOT LOOSEN EASILY. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18104678 ↗MalfunctionDec 1, 2022Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THE ORIGINAL PART RECEIVED WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15892748 ↗MalfunctionOct 19, 2022Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE INSTRUMENT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15635133 ↗MalfunctionJun 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE ATTUNE CALIPER WAS NOT WORKING PROPERLY. IT APPEARS A PIECE IS MISSING FROM THE TIGHTENING KNOB. PIECE WAS MISSING BEFORE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14602397 ↗MalfunctionJun 1, 2022Break; Material Deformation; Break; Material Deformation
THE SCREW TO THE CALIPER IS BENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14565507 ↗MalfunctionJan 17, 2022Mechanical Jam; Mechanical Jam
DURING A REPROCESSING OF A ATTUNE PATELLA CALIPER (869188), THE SCREW ON THE SIDE WAS STUCK AND WOULD NOT DISENGAGE. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13267158 ↗MalfunctionSep 15, 2021Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE LOCKING BOLT ON THE CALIPER IS LOOSE/ WOBBLING AND ON THE VERGE OF FALLING OFF ALL TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474206 ↗MalfunctionApr 9, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT THE KNEE INSTRUMENT WAS SCUFFED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641368 ↗MalfunctionMar 12, 2021Break; Break
IT WAS REPORTED THAT THE PATELLA CALPER LOCKING KNOB IS BROKEN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11476204 ↗MalfunctionJul 16, 2019Break; Break
CALIPER WAS FOUND TO BE BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8793253 ↗MalfunctionMay 20, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT UPON SET UP FOR TOTAL KNEE, THE SURGICAL TECHNOLOGIST NOTICED THAT THE SCREW ON CALIPER WAS BENT AND WOULD NOT LOOSEN OR TIGHTEN. THIS WAS NOTICED BEFORE SURGERY SO IT WAS NOT USED DURING THE SURGERY. THIS DID NOT DELAY THE SURGERY AND WILL SEND THE INSTRUMENT BACK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8625175 ↗MalfunctionAug 30, 2018Break; Break
IT WAS REPORTED THAT THE PATELLA CALIPER LOCKING PIN HAS SNAPPED OFF AND WILL NOT LOCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7834421 ↗MalfunctionDec 11, 2017Break; Break
IT WAS REPORTED THAT A BROKEN LOCKING MECHANISM WAS FOUND DURING CLEANING AND DID NOT IMPACT CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7104190 ↗MalfunctionAug 10, 2017Break; Break
IT WAS REPORTED THAT THE PIN IN THE CALIPER FELL OUT.
Patient problems: No Information
MAUDE report 6784540 ↗
Other TAPE, MEASURING, RULERS AND CALIPERS devices
- TRIGEN 71674079Smith & Nephew, Inc. · TAPE, MEASURING, RULERS AND CALIPERS454 reports
- TRIGEN 71631128Smith & Nephew, Inc. · TAPE, MEASURING, RULERS AND CALIPERS4 reports
- NA 03.501.065Synthes GmbH · TAPE, MEASURING, RULERS AND CALIPERS2 reports
- TRIGEN MAX 72502005Smith & Nephew, Inc. · TAPE, MEASURING, RULERS AND CALIPERS1 report
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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