NA 05.001.218Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886982129918), received between Jul 11, 2018 and Sep 11, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (17 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Excessive Heating

  It was reported that the reaming attachment device was heating up. It was not reported if the device was used in surgery. It was not reported if there were any delays in a surgical procedure or if a spare device was available. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733354 ↗
• MalfunctionApr 28, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE WAS FROZEN/WILL NOT MOVE, THE COLOR BAND WAS CHIPPING/FADING, MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY, AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING AND LABELING, CHECK FOR MECHANICAL FREE MOVEMENT, AND CHECK GENERAL FUNCTION IN RUNNING MODE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918009 ↗
• MalfunctionDec 2, 2024Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817239 ↗
• MalfunctionSep 19, 2024Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED BY INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256097 ↗
• MalfunctionJul 15, 2024Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED BY INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740248 ↗
• MalfunctionMay 1, 2024Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED BY INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221222 ↗
• MalfunctionMay 1, 2024Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED BY SINGAPORE THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED THAT THE DEVICE WAS INTERNALLY SEIZED, WOULD NOT MOVE AND THE CONE SLEEVE WAS JAMMED WITH THE STOP RING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220981 ↗
• MalfunctionSep 26, 2023Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Mechanical Jam; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD SEIZED MECHANICS, COSMETIC DAMAGE - WORN ETCH, COMPONENT DAMAGE, AND THE COLOR BAND WAS CHIPPING/FADING. IT WAS DETERMINED THAT THE ETCHING ON THE LABELING WAS ILLEGIBLE, AND THE DEVICE WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING AND LABELING, CHECK PINS LENGTH OF HANDPIECE COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE DEVICE WAS NOT WORKING PROPERLY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817061 ↗
• MalfunctionSep 7, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698343 ↗
• MalfunctionJul 7, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HUDSON REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD SEIZED MECHANICS AND WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECKING PINS LENGTH OF HANDPIECE COUPLING, CHECKING FOR MECHANICAL FREE MOVEMENT AND CHECKING GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279937 ↗
• MalfunctionJun 22, 2023Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING FOR K WIRES DEVICE WAS COULD NOT SECURE THE K DRIVE, HEATED UP AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR CHECK SELF-HOLDING FORCE IN SMALLEST RANGE AND FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185543 ↗
• MalfunctionJun 16, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HUDSON REAMING ATTACHMENT DEVICE HAD COSMETIC DAMAGE (WAS WORN), WOULD NOT MOVE (FROZEN), THE COLOR BAND WAS CHIPPING AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING & LABELING, CHECK PINS LENGTH OF HANDPIECE COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145581 ↗
• MalfunctionMay 12, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM KENYA THAT DURING POST-SURGERY: IT WAS DISCOVERED, THAT THE REAMING ATTACHMENT DEVICE HEATS UP EXCESSIVELY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924991 ↗
• MalfunctionNov 23, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD CORRODED BEARING, WAS FROZEN/WOULD NOT MOVE AND COLOR BAND WAS CHIPPING/FADING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING & LABELING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850619 ↗
• MalfunctionOct 13, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED BY GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE, HAD AN ILLEGIBLE LABELING ETCH, COULD NOT INSERT CUTTER, COULD NOT ENGAGE ATTACHMENT-COUPLING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING & LABELING, CHECK THE TOOL COUPLING, CHECK THE HANDPIECE COUPLING, CHECK PINS LENGTH OF HANDPIECE COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT FOLLOWING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE HAD A DAMAGED CLAMPING HEAD. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15596482 ↗
• MalfunctionSep 24, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY SINGAPORE THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE AND THE MECHANICS SEIZED AND WAS UNABLE TO RUN/ROTATE. IT WAS FURTHER OBSERVED THAT THE BALL BEARING IN THE HOUSING SEIZED AND WAS UNABLE TO BE REMOVED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476316 ↗
• MalfunctionSep 12, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY SINGAPORE THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE INTERNAL MECHANICS SEIZED, THE DEVICE WAS UNABLE TO ROTATE, AND THE LABELING WAS ILLEGIBLE AS THE RED COLOR CODING ON THE STOP RING HAD FADED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403481 ↗
• MalfunctionSep 12, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY (B)(4) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE ETCHING WAS ILLEGIBLE AND THE BEARING WAS WORN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING & LABELING, CHECK THE TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT, AND CHECK GENERAL FUNCTION IN RUNNING MODE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15400429 ↗
• MalfunctionSep 2, 2022Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HUDSON REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE DUE TO ITS CHUCK BEING SEIZED. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD ILLEGIBLE ETCH, SEIZED GEAR, COLOR BAND CHIPPING/FADING, CORRODED BEARING, AND CORROSION/RUSTING/PITTING. IT WAS DETERMINED THAT MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING AND LABELING, CHECKING FOR MECHANICAL FREE MOVEMENT AND CHECKING GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348838 ↗
• MalfunctionJun 23, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE REAMING ATTACHMENT DEVICE WAS OVERHEATING. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14786997 ↗
• MalfunctionJun 16, 2022Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HUDSON REAMING ATTACHMENT DEVICE CEASED UP AND WOULD NOT RUN. DURING DISASSEMBLY PROCESS, A IT WAS NOTED THAT THE BEARING WAS BROKEN AND STUCK INSIDE HOUSING. DURING FURTHER INVESTIGATION, IT WAS NOTED THAT THE BEARING DEVICE SEIZED, THE DRIVESHAFT WAS BROKEN, THE LOCKING MECHANISM STIFF/STUCK, WOULD NOT MOVE, WAS DIFFICULT TO ASSEMBLE / DISASSEMBLE, THE MOVING PARTS DID NOT MOVE SMOOTHLY, DID NOT FUNCTION AND COULD NOT ENGAGE THE ATTACHMENT DEVICE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR TOOL COUPLING, CANNULATION OF ATTACHMENT, MECHANICAL FREE MOVEMENT AND GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14713825 ↗
• MalfunctionSep 30, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE AND MOVING PARTS DID NOT MOVE SMOOTHLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE FREE MOVEMENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2021. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554820 ↗
• MalfunctionSep 14, 2021Device-Device Incompatibility; Premature Separation; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT THE REAMING ATTACHMENT DEVICE AND THE MONOBLOC FLEXIBLE REAMER DEVICE COULD NOT BE CONNECTED WELL. IT WAS REPORTED THAT THE SHAPE OF THE ATTACHMENT CONNECTION SEEMED TO BE CORRECT, BUT IT DID NOT LOCK AND CAME OFF WHEN PULLED. THE SURGEON COMMENTED THAT IT COULD NOT BE JUDGED WHETHER IT WAS A DEFECT OF THE INDIVIDUAL DEVICE OR A PROBLEM WITH THE STRUCTURE OF THE PRODUCT. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467151 ↗
• MalfunctionSep 21, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED FROM (B)(6) THAT THE REAMING ATTACHMENT DEVICE OVERHEATED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7897757 ↗
• MalfunctionJul 11, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING PRE-OPERATIVE CLEANING OF THE DEVICES IN PREPARATION FOR A HIGH TIBIAL OSTEOTOMY PROCEDURE, IT WAS OBSERVED THAT THE THREE ATTACHMENT DEVICES WERE LEAKING AN OIL LIKE OBJECT. IT WAS REPORTED THAT AFTER RE-STERILIZATION ANOTHER LEAKAGE WAS FOUND. IT IS UNKNOWN WHICH OF THE THREE DEVICES WERE LEAKING. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS SPARE DEVICES WERE AVAILABLE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7678960 ↗