CORAIL L93205Recalls & reported problems
Depuy (Ireland) · CORAIL AMT PROXIMAL COMPACTOR · Class 1
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295260707), received between Oct 23, 2018 and Sep 3, 2025 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Reports received per month
Most reported problems
Device problems
- Break4
- Naturally Worn4
- Contamination /Decontamination Problem2
- Insufficient Device Problem Information1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient5
- Insufficient Information1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT DURING THE STERILIZATION PROCESS CARRIED OUT AT THE HOSPITAL, A DARK LIQUID WAS RELEASED FROM THE IMPACTOR (SUSPECTED TO BE FROM THE CABLE). THE SCHEDULED SURGERY THAT WOULD USE THIS MATERIAL HAD TO BE CANCELED AND RESCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22952076 ↗MalfunctionNov 13, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON (B)(6) 2024, A BONE IMPACTOR WOODEN HANDLE HAD LEACHED COLOUR ONTO THE TRAY DURING/AFTER STERILISATION. THE HOSPITAL DECIDED IT WAS STILL CONSIDERED STERILE, SO STILL USED THE SET.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20677633 ↗MalfunctionApr 5, 2024Break; Break
THE HANDLE WAS REPORTED BROKEN BY THE MEDICAL DEVICE REPROCESSING DEPARTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19050374 ↗MalfunctionNov 6, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT INSTRUMENTS NEED REPLACING DUE TO WEAR AND TEAR AND ARE NO LONGER USABLE FOR SURGERY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT OR SURGERY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18081021 ↗MalfunctionMar 27, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT BONE IMPACTOR IS BLUNT. OVER 10 YEARS USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16620518 ↗MalfunctionMar 6, 2023Break; Break
THE BONE IMPACTOR HANDLE BROKE DURING ITS USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16490958 ↗MalfunctionMar 11, 2022Break; Break
HOSPITAL HAS COMMUNICATED THAT SEVERAL ITEMS NEEDED TO BE REPLACED DUE TO WEAR AND TEAR/ BREAKAGE. CORAIL IMPACTOR - BROKEN IN TWO PIECES WHEN IMPACTED. X2 FRAGMENTS. SCREW DRIVER NOT GRIPPING SCREW DUE TO WEAR AND TEAR. TRIAL HEADS - CAN'T READ SIZES DUE TO WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES OR SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13733428 ↗MalfunctionMay 22, 2019Break; Break
THE PART WHERE THE INSTRUMENT BROKE WAS AT THE RESIN SLEEVE AND WAS BROKEN INTO MANY FRAGMENTS. THE EVENT OCCURRED POST OP, AFTER THE DEVICE WAS TAKEN OUT OF THE CLEANING MACHINE, DETECTED DURING THE PACKAGING PROCESS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8633800 ↗MalfunctionMay 22, 2019Naturally Worn; Naturally Worn
ITEM WAS FLAGGED DURING THE STERILISATION PROCESS. NO ADVERSE EVENT REPORTED. NO FURTHER INFORMATION WAS PROVIDED. AFTER EVALUATION THE IMPACTOR WAS DETERMINED TO BE WORN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8631697 ↗MalfunctionFeb 12, 2019Naturally Worn; Naturally Worn
MDR STAFF HAS INDICATED PRODUCT L93606 (BONE TAMP IMPACTOR) WAS WORN AND DAMAGED. THE HANDLE WAS FOUND TO BE CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8332566 ↗MalfunctionNov 1, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THEY RECEIVED A CALL FROM THEIR LOCAL AGENT. IT WAS INDICATED THAT HE WILL LOG A PRODUCT COMPLAINT ABOUT THE PLC HOSPITAL SENDING DEPUY SYNTHES CONSIGNED INSTRUMENTATION AT A 3RD PARTY VENDOR FOR ¿SHARPENING¿ WITHOUT THEIR KNOWLEDGE OR APPROVAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8027816 ↗MalfunctionOct 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.