NA 530.705Recalls & reported problems
Synthes GmbH · BATTERY REAMER/DRILL II · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes Battery Reamer/Drill II is a battery-powered surgical drill. All 1,521 reports describe device malfunctions, mostly the drill sticking or resisting movement, losing power completely or intermittently, or jamming. The reports list no deaths and no injuries, and they describe equipment problems rather than patient harm. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,492
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,492 adverse event reports that list this exact device (DI 10886982240125), received between Nov 22, 2017 and Sep 30, 2026 — classified as 1,492 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (882 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.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking882
- Complete Loss of Power508
- Mechanical Jam160
- Intermittent Loss of Power123
- Unintended System Motion103
- Appropriate Device Problem Term/Code Not Available94
- Excessive Heating72
- Noise, Audible63
Patient problems
- No Clinical Signs, Symptoms or Conditions1,081
- No Consequences Or Impact To Patient322
- No Known Impact Or Consequence To Patient91
- Not Applicable1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 1,492 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Physical Resistance/Sticking; Complete Loss of Power
It was reported that during service and evaluation, it was determined that the battery reamer/drill device had a sticky trigger. It was noted in the service order that the device had no function. There was no delay in surgery. This event did not occur during surgery. 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 50949653 ↗MalfunctionSep 29, 2026Physical Resistance/Sticking; Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936079 ↗MalfunctionSep 29, 2026Physical Resistance/Sticking; Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935641 ↗MalfunctionSep 28, 2026Physical Resistance/Sticking; Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924175 ↗MalfunctionSep 28, 2026Intermittent Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924062 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
It was reported that the trigger of the battery reamer/drill device was detached. 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 50915138 ↗MalfunctionSep 25, 2026Physical Resistance/Sticking; Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902982 ↗MalfunctionJul 27, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50024831 ↗MalfunctionJul 1, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL DEVICE HAD A STICKY TRIGGER, THE MOTOR WAS WORN, WOULD NOT RUN, AND HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FOR STICKY TRIGGER, CHECK THE FUNCTION OF THE DEVICE, CHECK THE POWER WITH THE POWER TEST BENCH, AND MODE SWITCH-TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NON-FUNCTIONAL. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 25681925 ↗MalfunctionJul 1, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE HANDPIECE TRIGGER WAS NOT FUNCTIONING PROPERLY. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25681410 ↗MalfunctionJul 1, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 25680864 ↗MalfunctionJul 1, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS UNABLE TO WORK. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25678650 ↗MalfunctionJul 1, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOVING PARTS OF THE TRIGGER DID NOT MOVE SMOOTHLY ON THE BATTERY REAMER/DRILL DEVICE. IT WAS NOTED IN THE SERVICE ORDER THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE DEVICE DID NOT WORK EVEN WITH A BATTERY ATTACHED. THE DEVICE WAS USED IN CONJUNCTION WITH THE BATTERY OSCILLATOR AND BATTERY REAMER/DRILL DEVICES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. 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 25678494 ↗MalfunctionJul 1, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL DEVICE HAD INSUFFICIENT/LOW POWER AND A STICKY TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR STICKY TRIGGER AND CHECK THE POWER WITH THE POWER TEST BENCH. 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 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 25677876 ↗MalfunctionJun 26, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL FOR BPL II DEVICE TRIGGER MOVING PARTS DID NOT MOVE SMOOTHLY. 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 25641687 ↗MalfunctionJun 25, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL DEVICE HAD A STICKY TRIGGER AND WOULD NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR STICKY TRIGGERS, CHECK CANNULATION, CHECK THE FUNCTION OF THE DEVICE, AND CHECK POWER WITH THE POWER TEST BENCH. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 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 25621051 ↗MalfunctionJun 25, 2026Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL DEVICE HAD A STICKY TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR STICKY TRIGGERS. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS DEFECTIVE. 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 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 25620315 ↗MalfunctionJun 23, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL FOR BPL II DEVICE TRIGGER WAS STICKY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 25595372 ↗MalfunctionJun 22, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL DEVICE HAD A STICKY TRIGGER, HIGH OUTPUT/POWER, THE ELECTRICAL CONTROL UNIT (ECU WAS DAMAGED ¿ WILL NOT RUN, THE GEAR WAS WORN, AND THE BEARING WAS WORN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR STICKY TRIGGER, CHECK THE FUNCTION OF THE DEVICE, AND CHECK THE POWER WITH THE POWER TEST BENCH. 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 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 25585143 ↗MalfunctionJun 18, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25548070 ↗MalfunctionJun 18, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25547519 ↗MalfunctionJun 17, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL FOR BPL II DEVICE WAS JAMMED/SEIZED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT IN PROPER WORKING CONDITION. 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 25537058 ↗MalfunctionJun 15, 2026Complete Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL DEVICE HAD INTERMITTENT OPERATION. IT WAS REPORTED THAT THE ELECTRONIC CONTROL UNIT (ECU) WAS FAULTY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION OF THE DEVICE AND CHECK THE POWER WITH THE POWER TEST BENCH. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 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 25511322 ↗MalfunctionJun 15, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER/DRILL DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25510329 ↗MalfunctionJun 15, 2026Physical Resistance/Sticking; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOVING PARTS OF THE TRIGGER DID NOT MOVE SMOOTHLY ON THE BATTERY REAMER/DRILL DEVICE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25508462 ↗
Other MOTOR, SURGICAL INSTRUMENT, AC-POWERED devices
- NA 05.001.201Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,902 reports
- NA 530.710Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,800 reports
- NA 530.715Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED390 reports
- NA 530.730Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED267 reports
- NA 05.001.240Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED262 reports
- KINCISE™ 1000-00-101Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED242 reports
- NA 530.791Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED84 reports
- KINCISE™ 1011-01-101Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED51 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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