NA MDE001Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295262886), received between Oct 9, 2018 and Jun 13, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE THREE-PIECE EXTRACTOR WAS UNABLE TO BE SEPARATED DURING THE PROCEDURE. THE PROSTHESIS WAS ABLE TO BE EXTRACTED AND THE CASE WAS COMPLETED. THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203794 ↗
• MalfunctionSep 6, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE THREAD ON THE DISTAL END OF THE SLAP HAMMER SHEARED OFF INSIDE THE ADAPTER INSTRUMENT IT CONNECTS TO DURING USE RENDERING IT UNUSABLE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT NOR WAS SURGERY TIME INCREASED SIGNIFICANTLY. THE SURGEON SIMPLY USED ANOTHER INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162837 ↗
• MalfunctionAug 19, 2024Break; Break

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE THREAD OF THE INSTRUMENT IS CHIPPED. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19999830 ↗
• MalfunctionMar 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  MATCH ISSUE. IT WAS REPORTED THAT BEFORE THE SURGERY, NOTED THAT THE RETAINING STEM INSERTER DID NOT MATCH WITH THE EXTRACTION ROD(AS THE PHOTO SHOWS), AND THE THREADS COULD NOT COMPLETELY CONNECTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988036 ↗
• MalfunctionJan 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT BROKEN EXTRACTION ROD HAS WORN OUT ITS THREADS. PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, IP-01935909. DEVICE PROPERTY OF, NONE, DEVICE IN POSSESSION OF, NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475649 ↗
• MalfunctionNov 21, 2023Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP: A. PLEASE CLARIFY WHAT DO YOU MEAN BY DAMAGED? THE TIP/ THREAD IS WORN / DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187796 ↗
• MalfunctionAug 10, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE CORAIL EXTRACTOR FROM THE CORAIL REMOVAL SET WAS DAMAGED AND UNABLE TO BE USED. THERE WAS NO PATIENT CONSEQUENCE AND A 15 MINUTE DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17499665 ↗
• MalfunctionFeb 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EXTRACTION ROD, SLAP HAMMER AND SLAP HAMMER ADAPTOR ALL WELDED STUCK TOGETHER - NOW UNUSABLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303618 ↗
• MalfunctionOct 4, 2022Device-Device Incompatibility; Naturally Worn; Illegible Information; Device-Device Incompatibility; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE CORAIL EXTRACTOR AND SLAP HANDLE UNABLE TO SEPARATE FROM EACH OTHER. THEY SEEM COLD WELDED SOME HOW. THE CORAIL EXTRACTOR THREAD IS DAMAGED AND ALSO NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536784 ↗
• MalfunctionJun 13, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SET SCREW ON THE RECLAIM PROX BODY WAS STRIPPED AND RUNG OFF WHEN TIGHTENED. EXTRACTION ROD HAS DAMAGED THREADS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675467 ↗
• MalfunctionJun 2, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  VARIOUS ITEMS HAVE BEEN IDENTIFIED AS NEEDING TO BE REPLACED DUE TO WEAR AND TEAR. NO IMPACT TO PATIENT BUT THESE ARE NO LONGER VIABLE TO USE AND NEED TO BE REPLACED FOR AN UPCOMING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920742 ↗
• MalfunctionMar 26, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  CORAIL EXTRACTION INSTRUMENTS COLD - WELDED TOGETHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9883384 ↗
• MalfunctionOct 9, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT STEM REMOVAL TOOL THREADS ARE STRIPPED AND COLD WELDED TO THE SLAP HAMMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7947675 ↗