NA SHORT-HDRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00845384008804), received between Apr 2, 2019 and May 28, 2025 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (18 reports).

70 other recalls cover devices cleared under the same FDA submission (K011444); 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. 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SHORT ATTACHMENT DEVICE WAS COMING APART AND A METAL PIECE WAS LOOSE INSIDE. 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 22094396 ↗
• MalfunctionAug 14, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE DISCONNECTED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19981635 ↗
• MalfunctionApr 4, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE COULD NOT BE SECURED TO THE MOTOR DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE ATTACHMENT FELL APART ¿ UNATTACHED. IT WAS FURTHER DETERMINED THAT THE COLOR BAND WAS CHIPPING/FADING AND THE DEVICE WAS MISSING COMPONENTS. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, COLOR BAND VISUAL ASSESSMENT AND LOCK OPERATION. 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 FOR USE. THERE WERE NO REPORTS OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16673644 ↗
• MalfunctionFeb 2, 2023Excessive 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 WORN BEARING AND STIFF/STUCK LOCKING MECHANISM. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LOCK OPERATION VERIFICATION AND TEMPERATURE VERIFICATION. 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 16284822 ↗
• MalfunctionDec 19, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED BY THE NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE PRODUCED HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VERIFICATION: TEMPERATURE (STRAIGHT 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 UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. 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 16002881 ↗
• MalfunctionJun 7, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD A WORN BEARING, PRODUCED HEAT, HAD AN ILLEGIBLE LABELING ETCH AND COULD NOT SECURE/LOCK CUTTER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, VERIFICATION: LOCK OPERATION AND VERIFICATION: 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 THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. 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 14615563 ↗
• MalfunctionMay 16, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE BEARING WAS WORN AND OVERHEATED. THE DEVICE ALSO FAILED PRETESTS FOR 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 DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE 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 14408223 ↗
• MalfunctionMar 3, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE SHORT ATTACHMENT DEVICE WAS OVERHEATING, THE BEARING WAS WORN AND THE ETCHING WAS ILLEGIBLE. THE DEVICE ALSO FAILED PRETESTS FOR LABELING ASSESSMENT AND TEMPERATURE ASSESSMENT. 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 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 13662434 ↗
• MalfunctionMar 3, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD A WORN BEARING, HEAT, THE TRIANGLE ICON WAS MISSING, THE ETCHING WAS ILLEGIBLE, AND THE LABELING WAS MISSING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, AND TEMPERATURE ASSESSMENT. 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 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 13660011 ↗
• MalfunctionFeb 28, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD A WORN BEARING, PRODUCED HEAT AND HAD AN ILLEGIBLE LABELLING ETCH. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT AND VERIFICATION: TEMPERATURE. IT WAS NOTED THAT THE TRINGLE ICON WAS MISSING AND AN ADDITIONAL LABEL WAS ADDED TO THE EXTENSION SLEEVE BY THE CUSTOMER. 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 AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619190 ↗
• MalfunctionJul 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE METAL RING DETACHED. IT WAS UNKNOWN IF THERE WERE DELAYS TO THE SURGICAL PROCEDURE. A SPARE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12148977 ↗
• MalfunctionApr 8, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE INNER MATERIAL WAS FLAKING OFF. 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 11635204 ↗
• MalfunctionMar 25, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD HEAT, THE LABELING WAS MISSING AND HAD AN ILLEGIBLE ETCH, AND THERE WAS BEARING DAMAGE. IT WAS NOTED THAT THE TRIANGLE SYMBOL WAS MISSING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING AND TEMPERATURE ASSESSMENT. 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 2021. 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 11570134 ↗
• MalfunctionMar 8, 2021Vibration; Noise, Audible; Vibration; Noise, Audible

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE RATTLED WHEN SHAKEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS VIBRATING AND THE BEARING WAS WORN. THE DEVICE ALSO FAILED PRETESTS FOR VIBRATION. 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 11440159 ↗
• MalfunctionFeb 25, 2021Vibration; Noise, Audible; Vibration; Noise, Audible

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE HAD A "SHAKING METHOD" AND RATTLED DURING TESTING. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD VIBRATION, COSMETIC DAMAGE, COMPONENT DAMAGE AND FAILED PRE-TEST FOR VISUAL AND VIBRATION ASSESSMENT. 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. 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 11377871 ↗
• MalfunctionFeb 4, 2021Vibration; Excessive Heating; Vibration; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD BEARING DAMAGE, MISSING LABELING, VIBRATION, HEAT AND ILLEGIBLE ETCH. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING, VIBRATION AND 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 THE EVENT WAS UNKNOWN. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282664 ↗
• MalfunctionFeb 4, 2021Vibration; Excessive Heating; Vibration; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD BEARING DAMAGE, THE LABELING (TRIANGLE SYMBOL) WAS MISSING, VIBRATION, HEAT, AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, VIBRATION, AND 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 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282276 ↗
• MalfunctionDec 22, 2020Vibration; Excessive Heating; Vibration; Excessive Heating

  IT WAS REPORTED BY NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BALL BEARINGS AND BEARING OF THE ATTACHMENT DEVICE WERE WORN, AND THE TRIANGLE SYMBOL WAS MISSING. IT WAS DETERMINED THAT THE DEVICE GENERATED HEAT AND VIBRATION, AND THE LABELING WAS ILLEGIBLE AND ETCHING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, VIBRATION AND 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 THE EVENT WAS UNKNOWN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11058381 ↗
• MalfunctionDec 22, 2020Vibration; Excessive Heating; Vibration; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS MARKED WITH A FOREIGN MARKING "6070", THE BEARINGS WERE WORN, THE TRIANGLE SYMBOL WAS MISSING, THE DEVICE HAD HEAT, THE LABELING WAS MISSING, AND THE DEVICE HAD VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, VIBRATION, AND TEMPERATURE ASSESSMENT. 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 2020. 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 11055540 ↗
• MalfunctionOct 20, 2020Vibration; Excessive Heating; Vibration; Excessive Heating

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BEARING OF THE ATTACHMENT DEVICE WAS WORN. IT WAS DETERMINED THAT THE DEVICE GENERATED HEAT AND VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VIBRATION AND 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 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 10706071 ↗
• MalfunctionOct 13, 2020Vibration; Excessive Heating; Vibration; Excessive Heating

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE ATTACHMENT DEVICE WOULD NOT SEAT OR LOCK APPROPRIATELY WHILE BEING USED WITH A MOTOR DEVICE. IT WAS REPORTED THAT THE PROCEDURE WAS DELAYED 5-10 MINUTES WHILE TROUBLE SHOOTING AND OPENING A SPARE DRILL DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD HEAT AND VIBRATION, THE DEVICE WAS WORN, HAD CORROSION/RUSTING/PITTING, AND THE COLOR BAND CHIPPING/FADING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRE-TEST FOR COLOR BAND FADING, VIBRATION AND TEMPERATURE. IT WAS REPORTED THAT THE DEVICE WAS USED IN SURGERY AND THERE WAS 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 10671215 ↗
• MalfunctionOct 6, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING STERILE PROCESSING, WHILE PERFORMING THE ASSEMBLY INSPECTION CHECK PROCESS IT WAS OBSERVED THAT THE ATTACHMENT DEVICE INNER SPRING-CLIP WAS BENT OUTWARDS. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD HEAT AND WORN BEARINGS, THE COLOR BAND WAS FADING, AND THE SNAP RING WAS DAMAGED. THE DEVICE ALSO FAILED PRETESTS FOR VISUAL ASSESSMENT AND TEMPERATURE ASSESSMENT. 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. 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 10635553 ↗
• MalfunctionSep 8, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BEARING OF THE ATTACHMENT DEVICE WAS WORN. IT WAS DETERMINED THAT THE DEVICE GENERATED HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR 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 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 10503373 ↗
• MalfunctionSep 3, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE WAS OVERHEATING. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED 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 Consequences Or Impact To Patient

  MAUDE report 10490667 ↗
• MalfunctionFeb 3, 2020Vibration; Excessive Heating; Vibration; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE BEARING WAS WORN AND THE TRIANGLE SYMBOL WAS MISSING. THE DEVICE ALSO FAILED PRETESTS FOR PRELOAD, VIBRATION AND TEMPERATURE ASSESSMENT. 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 2019. 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 9660002 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011444. One submission often covers many models, so check the product and lot details in each record.

• Z-0920-2023 · Dec 7, 2022 · Open, Classified
  7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
• Z-0923-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
• Z-0921-2023 · Dec 7, 2022 · Open, Classified
  Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
• Z-0918-2023 · Dec 7, 2022 · Open, Classified
  Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
• Z-0924-2023 · Dec 7, 2022 · Open, Classified
  Pediatric Craniotome Ref:CRANI-P-G1
• Z-0919-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
• Z-0922-2023 · Dec 7, 2022 · Open, Classified
  7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
• Z-0916-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
• Z-0917-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and crani
• Z-1986-2017 · Oct 6, 2016 · Terminated
  Adult Craniotome Product Usage: Pneumatic system
• Z-2002-2017 · Oct 6, 2016 · Terminated
  10.5cm Long Attachment Product Usage: Pneumatic system
• Z-2000-2017 · Oct 6, 2016 · Terminated
  10.5cm Long Attachment, Non-Tapered End Product Usage: Pneumatic system
• Z-2013-2017 · Oct 6, 2016 · Terminated
  8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic system
• Z-2024-2017 · Oct 6, 2016 · Terminated
  8cm QD Angle Attachment
• Z-1990-2017 · Oct 6, 2016 · Terminated
  Rotating Large Craniotome

…and 55 more.