NA 530.783Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982240231), received between Jun 16, 2020 and Jun 1, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Leak/Splash

  IT WAS REPORTED THAT THE REAMING ATTACHMENT DEVICE HAD OIL RUNNING OUT OF IT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE. 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 2026. 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 25350696 ↗
• 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 2 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059913 ↗
• MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING POST-SURGERY CLEANING, IT WAS DISCOVERED THAT A PART CAME OFF THE REAMING ATTACHMENT DEVICE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826048 ↗
• MalfunctionAug 28, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION; IT WAS DETERMINED THAT THE 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 EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913081 ↗
• 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 MOD TINKLE 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 16505773 ↗
• MalfunctionJun 19, 2020Excessive Heating; Excessive Heating

  THIS IS EVENT 5 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 10174308 ↗
• MalfunctionJun 16, 2020Excessive Heating; Excessive Heating

  THIS IS REPORT 7 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 10159788 ↗