NA 530.782Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982240224), received between Jun 11, 2020 and Jan 13, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED THAT THE TWO (X2) ATTACHMENT DEVICES CONNECTIONS WERE WEAK AND TENDED TO DETACH EASILY. 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 FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058674 ↗
• MalfunctionAug 28, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE HUDSON REAMING ATTACHMENT DEVICE WAS BROKEN (2+ PIECES) CHIPPED/SHAVED/DELAMINATED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915794 ↗
• MalfunctionJun 11, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE HUDSON REAMING ATTACHMENT DEVICE WAS BROKEN INTO TWO PIECES, THE LABELING WAS CHIPPED/SHAVED/DELAMINATED - AND THE ETCHING WAS ILLEGIBLE. THE DEVICE ALSO FAILED PRETESTS FOR MARKINGS. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186453 ↗
• MalfunctionAug 9, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HUDSON REAMING DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR 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 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 19947276 ↗
• MalfunctionJan 19, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM NETHERLANDS THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE HUDSON REAMING DEVICE HEATED UP. THE DEVICE ALSO FAILED PRETESTS FOR 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 DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE 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 18542086 ↗
• MalfunctionMar 8, 2023Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT DURING AN OSTEOSYNTHESIS SURGICAL PROCEDURE FOR FEMORAL TROCHANTERIC FRACTURE, IT WAS DISCOVERED THAT THE HUDSON REAMING ATTACHMENT DEVICE BECAME HOT AND HAD LOWER THAN NORMAL ROTATIONS PER MINUTE. IT WAS REPORTED THAT WAS LESS THAN 30-MINUTE DELAY TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506153 ↗
• MalfunctionJun 19, 2020Excessive Heating; Excessive Heating

  THIS IS EVENT 4 OF 5 OF THE SAME EVENT IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BATTERY REAMER DEVICE, BATTERY OSCILLATOR DEVICE, CHUCK DEVICE, TWO REAMING ATTACHMENT DEVICES, AND THREE BATTERY DEVICES WERE OVERHEATING AND EMITTED AN ABNORMAL NOISE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. THERE WAS 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 10174305 ↗
• MalfunctionJun 16, 2020Excessive Heating; Excessive Heating

  THIS IS REPORT 6 OF 7 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT TWO BATTERY RECIPROCATOR DEVICES, A BATTERY REAMER/DRILL DEVICE, A BATTERY OSCILLATOR DEVICE, A CHUCK WITH KEY DEVICE, TWO REAMING ATTACHMENT DEVICES, AND A BATTERY DEVICE WERE MAKING ABNORMAL NOISE AND GENERATING HEAT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF ANY 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 Consequences Or Impact To Patient

  MAUDE report 10159781 ↗
• MalfunctionJun 11, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WAS FROZEN/SEIZED, WOULD NOT MOVE. THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142634 ↗