NA MA-15CRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00845384004325), received between Jan 24, 2018 and Apr 30, 2025 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (14 reports).

31 other recalls cover devices cleared under the same FDA submission (K042783); they may or may not involve this specific model.

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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Device Reprocessing Problem; Noise, Audible; Excessive Heating; Device Reprocessing Problem; Noise, Audible; Excessive Heating

  IT WAS NOTED IN THE SERVICE ORDER THAT THE BEARING SLEEVE DEVICE HAD BLACK DIRT EMERGING FROM IT AND WAS PRODUCING AN ABNORMAL NOISE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE GENERATED HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD A WORN BEARING, COMPONENT DAMAGE AND VIBRATION. IT WAS OBSERVED THAT THE DEVICE PRODUCED AN UNEXPECTED NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT AND TEMPERATURE ASSESSMENT. 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 21933905 ↗
• MalfunctionFeb 27, 2024Mechanical Jam; Excessive Heating; Mechanical Jam; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BEARING SLEEVE HAD A WORN BEARING, COMPONENT DAMAGE, WAS MAKING AN UNEXPECTED/ABNORMAL NOISE, HAD VIBRATION, AND HAD HEAT GENERATION. IT WAS NOTED THAT THE SHAFT WAS FLAWED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT AND TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT ROTATE SMOOTHLY. 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 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 18787630 ↗
• MalfunctionSep 27, 2023Premature Separation; Premature Separation

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM JAPAN THAT THE BURR DEVICE DETACHED FROM THE BEARING SLEEVE DEVICE. 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. 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 17827379 ↗
• MalfunctionJul 27, 2023Vibration; Excessive Heating; Vibration; Excessive Heating

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CURVED BEARING SLEEVE DEVICE HAD A WORN BEARING, DAMAGED COMPONENTS, PRODUCED HEAT AND HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT AND TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE PRODUCED VIBRATION. 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 AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405689 ↗
• MalfunctionJul 14, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BEARING SLEEVE USED WITH THE ATTACHMENT DEVICE FAILED VISUAL INSPECTION DUE TO COMPONENT DAMAGE. DURING THE ASSESSMENT IT WAS FOUND THAT THE SLEEVE WAS DAMAGED ON THE TIP. FURTHERMORE, IT WAS DETECTED THAT THE DEVICE EXCEEDED THE TEMPERATURE ON THE MEASURING POINT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT AND TEMPERATURE ASSESSMENT (SLEEVE ONLY). 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 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 17324836 ↗
• MalfunctionJun 8, 2023Device-Device Incompatibility; Excessive Heating; Device-Device Incompatibility; Excessive Heating

  IT WAS REPORTED THAT THE MOTOR DEVICE WOULD NOT HOLD THE CUTTER DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE TIP WAS DAMAGED (HAD COMPONENT DAMAGE) AND WAS HEATING UP. THE DEVICE ALSO FAILED PRETESTS FOR VISUAL ASSESSMENT AND TEMPERATURE ASSESSMENT. 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 DATE OF 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 17089017 ↗
• MalfunctionApr 20, 2023Device-Device Incompatibility; Excessive Heating; Device-Device Incompatibility; Excessive Heating

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BEARING SLEEVE DEVICE COULD NOT BE REMOVED FROM THE MINIMAL ACCESS DRIVER DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS OBSERVED THAT THE DEVICE'S PART HAS PHYSICAL DAMAGE AND THE DEVICE'S TEMPERATURE IS MORE (HEAT). 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 16778055 ↗
• MalfunctionJan 26, 2023Excessive Heating; Excessive Heating

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE AND BEARING SLEEVE DEVICE EXPERIENCED EXCESSIVE FRICTION AND HEATED UP WHILE IN USE. IT WAS REPORTED THAT THE DEVICES WERE BEING USED TOGETHER WHEN THE EVENT OCCURRED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 16245832 ↗
• MalfunctionJun 29, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS GENERATING HEAT. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD COSMETIC DAMAGE AND VIBRATION. IT WAS DETERMINED THAT THE DEVICE WAS MAKING UNEXPECTED NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT AND MAXIMUM TEMPERATURE OF SLEEVE. 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 14856759 ↗
• InjuryJun 23, 2021Excessive Heating; Excessive Heating

  THIS IS REPORT 5 OF 5 OF THE SAME EVENT: IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE BECAME VERY HOT, CAUSING THE SURGEON TO SUFFER FROM A FIRST-DEGREE BURN TO THE FINGER. IT WAS REPORTED THAT THE MOTOR DEVICE WAS HEATING UP WHILE CONNECTED TO THE ATTACHMENT AND THE BEARING SLEEVE DEVICE; AND THE ATTACHMENT BECAME TOO HOT TO TOUCH, BURNING THE SURGEON¿S FINGER. IT WAS FURTHER REPORTED THAT THE BURNT FINGER DRAPED WHILE THE SURGEON TRIED TO SWITCH TO A DIFFERENT ATTACHMENT DEVICE, WHICH WAS ALSO CONNECTED TO A BEARING SLEEVE. THE REPORTER CLARIFIED THAT THEY DID NOT KNOW WHETHER A MALFUNCTION OCCURRED WITH THE ATTACHMENT DEVICES BECAUSE SINCE THE DRILL WAS HOT, THE ATTACHMENTS WERE NEVER CHANGED AND THEREFORE, WERE NEVER CHECKED FOR ANY MALFUNCTIONS. IT WAS REPORTED THAT THERE WAS LESS THAN A THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. IT WAS REPORTED THAT THE SURGEON DID NOT RECEIVE ANY TREATMENT. THERE WERE NO REPORTS OF MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF AD

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 12053273 ↗
• MalfunctionApr 15, 2021Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE BEARING SLEEVE DEVICE WAS OVERHEATING. THE DEVICE ALSO FAILED PRETEST FOR MAX TEMPERATURE OF SLEEVE. 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 2021. 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 11674782 ↗
• MalfunctionApr 5, 2021Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE BEARING SLEEVE DEVICE WAS OVERHEATING. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2021. 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 11616612 ↗
• MalfunctionApr 5, 2021Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE BEARING SLEEVE DEVICE WAS OVERHEATING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MAX TEMPERATURE OF SLEEVE. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2021. 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 11616586 ↗
• MalfunctionMay 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS EVENT 2 OF 2 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT PARTS OF THE MINIMAL ACCESS ATTACHMENT DEVICE AND THE BEARING SLEEVE HAD DROPPED WHEN USED TOGETHER. 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. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2020. 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 10043994 ↗
• MalfunctionMay 7, 2020Vibration; Excessive Heating; Vibration; Excessive Heating

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BEARING SLEEVE DEVICE GENERATED HEAT AND VIBRATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE BURR DEVICE DID NOT ROTATE PROPERLY. 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 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10032234 ↗
• MalfunctionFeb 13, 2020Vibration; Vibration

  IT WAS REPORTED FROM (B)(6) THAT THE BEARING SLEEVE DEVICE WAS SHAKING. IT WAS FURTHER REPORTED THAT THE SHAKING OCCURRED IN THE CUTTER BAR. 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 DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2019. 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 9706404 ↗
• MalfunctionFeb 7, 2020Vibration; Vibration

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BEARING SLEEVE HAD VIBRATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. 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 9682977 ↗
• MalfunctionDec 10, 2019Detachment of Device or Device Component; Excessive Heating; Detachment of Device or Device Component; Excessive Heating

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN ENDOSCOPIC LUMBAR LAMINECTOMY MEPD MILD SURGICAL PROCEDURE FOR A LUMBAR SPINAL CANAL STENOSIS (ARTHROSCOPIC ABLATION FOR ARCH OF LUMBAR VERTEBRA) IT WAS OBSERVED THAT AFTER 3 TO 5 MINUTES OF CUTTING OUT BONE WITH A MINIMAL ACCESS DRIVER DEVICE, BEARING SLEEVE DEVICE, AND CUTTER DEVICE, THE HANDLE OF THE DEVICE HAD BECOME QUITE HEATED, AND THE BAR OF THE CUTTING BURR DEVICE IMMEDIATELY BROKE OFF. IT WAS REPORTED THAT THE DEVICE DROVE AT 80,000 ROTATIONS PER MINUTE (RPM) DURING THE ABLATION. IT WAS REPORTED THAT THERE WAS A FIVE-MINUTE DELAY 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 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 9443928 ↗
• MalfunctionJun 28, 2019Vibration; Vibration

  IT WAS REPORTED FROM (B)(6) THAT DURING EVALUATION OF THE BEARING SLEEVE DEVICE, IT WAS DETERMINED THAT THE DEVICE HAD VIBRATION AND WAS MAKING AN UNEXPECTED NOISE. IT WAS NOTED IN THE SERVICE ORDER THAT THE CUTTING BURR DEVICES WERE NOT ROTATING SMOOTHLY. 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 2019. 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 8744028 ↗
• MalfunctionJun 10, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED FROM (B)(6) THAT THE CUTTER DEVICE WAS STUCK IN THE BEARING SLEEVE DEVICE AND THE ATTACHMENT DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE OVERHEATED 119 DEGREES DUE TO THE WORN OUT BEARINGS. 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 8685210 ↗
• MalfunctionJun 7, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE BEARING SLEEVE 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. THE DATE OF 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 Known Impact Or Consequence To Patient

  MAUDE report 8679218 ↗
• MalfunctionApr 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT THE COMPONENTS FROM EITHER THE ATTACHMENT DEVICE OR THE BEARING SLEEVE DEVICE DROPPED OUT. HOWEVER, THE REPORTER WAS NOT SURE EXACTLY WHICH DEVICE HAD THE ISSUE. 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. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2019. 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 8548946 ↗
• MalfunctionJul 11, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE BEARING SLEEVE ATTACHMENT DEVICE STARTED HEATING UP AND HAD BAD BEARINGS. 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 NOTED THAT THE EVENT OCCURRED IN 2018. 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 7677262 ↗
• MalfunctionJun 13, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BEARING SLEEVE DEVICE HAD AN UNDETERMINED MALFUNCTION WHILE IN USE WITH THE CUTTER DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE BEARING SLEEVE DEVICE HAD EXCEEDED THE MAXIMUM ALLOWABLE TEMPERATURE. 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 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 Consequences Or Impact To Patient

  MAUDE report 7597670 ↗
• MalfunctionApr 3, 2018Output below Specifications; Output below Specifications

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING A LAMINECTOMY PROCEDURE, IT WAS OBSERVED THAT THE MOTOR DEVICE SEEMED TO LOSE POWER WHILE IN USE WITH A BEARING SLEEVE DEVICE AND AN ATTACHMENT DEVICE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. HOWEVER, IT WAS REPORTED THAT THE SAME MOTOR DEVICE WAS USED TO COMPLETE THE 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 7393604 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042783. One submission often covers many models, so check the product and lot details in each record.

• Z-2003-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system
• Z-2007-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system
• Z-2005-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system
• Z-2006-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system
• Z-2011-2017 · Oct 6, 2016 · Terminated
  Minimal Access Straight Driver Product Usage: Pneumatic system
• Z-2009-2017 · Oct 6, 2016 · Terminated
  Minimal Access Attachment Product Usage: Pneumatic system
• Z-2004-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system
• Z-0708-2014 · Oct 26, 2012 · Terminated
  Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, M
• Z-0755-2014 · Mar 29, 2012 · Terminated
  MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as c
• Z-0756-2014 · Mar 29, 2012 · Terminated
  MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochl
• Z-0766-2014 · Mar 29, 2012 · Terminated
  MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochl
• Z-0767-2014 · Mar 29, 2012 · Terminated
  MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as coch
• Z-0764-2014 · Mar 29, 2012 · Terminated
  MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as co
• Z-0753-2014 · Mar 29, 2012 · Terminated
  MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as c
• Z-0750-2014 · Mar 29, 2012 · Terminated
  MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as

…and 16 more.