NA 511.30Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982237385), received between Jan 29, 2018 and Jul 29, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE RADIOLUCENT DRIVE DEVICE INTERNAL COMPONENT WOULD NOT TURN. 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. 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 22641621 ↗
• MalfunctionJun 8, 2023Mechanical Jam; Noise, Audible; Difficult or Delayed Separation; Mechanical Jam; Noise, Audible; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE RADIOLUCENT DRIVE DEVICE WAS MAKING A CLICKING SOUND, WOULD NOT DRIVE FORWARD, AND WAS HARD TO ATTACH. 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 17088641 ↗
• MalfunctionJan 7, 2021Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT THE RADIOLUCENT DRIVE DEVICE DID NOT SPIN WHEN ATTACHED TO THE DRILL. 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. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. 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 11131546 ↗
• MalfunctionMar 11, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE RADIOLUCENT DRIVE DRILL BIT FLIPPED WITH PRESSURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. 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 8407929 ↗
• MalfunctionMay 23, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RADIOLUCENT DRIVE DEVICE COUPLING ON THE TOOL SIDE WAS WORN AND THE DRILL RECEPTIVE CAME OUT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE UNTRUE RUNNING, CHECK THE MACHINE COUPLING AND CHECK THE TOOL COUPLING. 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 Consequences Or Impact To Patient

  MAUDE report 7538103 ↗
• MalfunctionApr 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RADIOLUCENT DRIVE DEVICE WAS DROPPED CAUSING WHERE THE CUTTER DEVICE CONNECTS TO THE HANDLE TO BREAK OFF AND HOUSING WAS CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE HOUSING WAS BROKEN OFF AND SLIDING SLEEVE CAME OFF DUE TO THE BROKEN HOUSING. 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 Known Impact Or Consequence To Patient

  MAUDE report 7457667 ↗
• MalfunctionApr 6, 2018Device Inoperable; Noise, Audible; Device Inoperable; Noise, Audible

  THIS IS REPORT 1 OF 4 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGICAL PROCEDURE FOR A HUMERUS DIAPHYSIS FRACTURE USING THE MULTI-HUMERAL NAIL LONG (MHN LONG) DEVICE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE STOPPED WORKING WHILE DRILLING THE FIRST DISTAL HOLE. ACCORDING TO THE REPORT, THE EVENT OCCURRED AFTER A PROXIMAL HOLE WAS FIXED. IT WAS REPORTED THAT THE SMALL BATTERY DRIVE DEVICE WAS IN USE WITH A RADIOLUCENT DRIVE DEVICE, ADAPTOR DEVICE AND A QUICK COUPLING DEVICE. IT WAS FURTHER REPORTED THAT THE SMALL BATTERY DRIVE DEVICE KEPT RUNNING IDLE WITH A SCRATCHING SOUND. IT WAS REPORTED THAT THE SURGEON REASSEMBLED THE UNIT AGAIN AND TRIED DRILLING BUT COULD NOT COMPLETE THE DRILLING AS THE SAME ISSUE OCCURRED. AS A RESULT, THE SURGEON CREATED THE PREPARED HOLE WITH A GIMLET AND THEN DRILLED BY HAND. IT WAS REPORTED THAT THE SAME EVENT OCCURRED AT THE SECOND HOLE BUT THE SURGEON COMPLETED DRILLING USING THE SAME MANUAL WAY. IT WAS REPORTED THAT THE SURGEON TOOK TIME TO CHANGE THE BATTERY AND TRIED THE SAME WAY AT THE THIRD HOLE. IT WAS REPORTED THAT ALTHOUGH THE SMALL BATTERY DRIVE DEVICE WAS ABOUT TO STO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7404030 ↗
• MalfunctionMar 9, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED FROM (B)(6) THAT THE RADIOLUCENT DRIVE DEVICE COUPLING HAD A GREASE LEAK. 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 Known Impact Or Consequence To Patient

  MAUDE report 7327780 ↗
• MalfunctionMar 5, 2018Vibration; Vibration

  IT WAS REPORTED FROM (B)(6) THAT THE RADIOLUCENT DEVICE "RUCENT" ITSELF ROTATES AND HAD ABNORMAL ROTATION. 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. THE EXACT DATE OF THIS EVENT IS UNKNOWN. 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 7312566 ↗
• MalfunctionJan 29, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED FROM (B)(6) THAT THE RADIOLUCENT DRIVE MARK 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. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7225387 ↗