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NA QD11-G1Recalls & reported problems

Synthes GmbH · 11 cm QD Angle Attachment, G1 · Class 2

Quick summary

This Synthes QD angle attachment is a powered tool accessory that connects to a surgical drill, used in bone surgery. Most of the 312 reports describe the attachment overheating, and some describe vibration or a complete loss of power. There was 1 injury report and no deaths, and no recalls name this device. Reports fell to 8 in the latest 12 months from 14 in the 12 months before.

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
312
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 312 adverse event reports that list this exact device (DI 00845384016380), received between Jan 4, 2018 and Apr 16, 2026 — classified as 1 injury, 311 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (212 reports).

11 other recalls cover devices cleared under the same FDA submission (K133604); 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 3 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 4 reportsSep 2024: 6 reportsOct 2024: 1 reportsNov 2024: 3 reportsDec 2024: 1 reportsJan 2025: 1 reportsFeb 2025: 1 reportsMar 2025: 2 reportsApr 2025: 2 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 3 reportsDec 2025: 1 reportsJan 2026: 2 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Excessive Heating212
  • Overheating of Device55
  • Vibration51
  • Complete Loss of Power25
  • Device-Device Incompatibility5
  • Appropriate Device Problem Term/Code Not Available4
  • Detachment of Device or Device Component3
  • Fail-Safe Did Not Operate3

Patient problems

  • No Clinical Signs, Symptoms or Conditions186
  • No Consequences Or Impact To Patient99
  • No Known Impact Or Consequence To Patient26
  • Burn(s)2

Recent adverse event reports

The 25 most recent of 312 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 16, 2026Excessive Heating

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE PRODUCED HEAT. 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 24895013 ↗
  • MalfunctionFeb 4, 2026Excessive Heating

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE EXPERIENCED SEVERE OVERHEATING AT THE ANGLED PORTION. 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24259056 ↗
  • MalfunctionJan 26, 2026Excessive Heating

    IT WAS REPORTED THAT THE ANGLE ATTACHMENT DEVICE HAD AN OVERHEATING ISSUE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE, 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 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 24178888 ↗
  • MalfunctionJan 26, 2026Excessive Heating

    IT WAS REPORTED THAT THE ANGLE ATTACHMENT DEVICE HAD AN OVERHEATING ISSUE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE, 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 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 24178613 ↗
  • MalfunctionDec 23, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE HAD AN OVERHEATING ISSUE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23878720 ↗
  • MalfunctionNov 21, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE EXPERIENCED AN OVERHEATING ISSUE. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23616226 ↗
  • MalfunctionNov 5, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE HAD A SEVERE OVERHEATING 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. 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 23476286 ↗
  • MalfunctionNov 3, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE HAD AN OVERHEATING ISSUE. 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23457908 ↗
  • MalfunctionAug 15, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE ANGLE ATTACHMENT DEVICE HAD A SEVERE OVERHEATING ISSUE. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22816593 ↗
  • MalfunctionAug 15, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE ANGLE ATTACHMENT DEVICE HAD A SEVERE OVERHEATING ISSUE. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22815950 ↗
  • MalfunctionJun 16, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE WAS HEATING UP. 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 2024. 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 22212311 ↗
  • MalfunctionMay 8, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE CONNECTOR ASSEMBLY ON THE ATTACHMENT DEVICE WAS HOT. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21984736 ↗
  • MalfunctionApr 25, 2025Excessive Heating; Excessive Heating

    THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE TEMPERATURE OF TWO ATTACHMENT DEVICES WAS HIGH. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY. 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 21912881 ↗
  • MalfunctionApr 23, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE HEATED UP. 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 21889133 ↗
  • MalfunctionMar 24, 2025Device-Device Incompatibility; Excessive Heating; Device-Device Incompatibility; Excessive Heating

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE PRODUCED HEAT AND WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MOTOR ENGAGEMENT ASSESSMENT AND TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT COUPLING WITH THE CUTTING TOOL. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21676414 ↗
  • MalfunctionMar 6, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE COULD NOT SECURE/LOCK CUTTER, HEATED UP AND 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 DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21536801 ↗
  • MalfunctionFeb 6, 2025Fail-Safe Problem; Appropriate Device Problem Term/Code Not Available; Fail-Safe Problem; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE RAN IN LOCKED POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MOTOR ENGAGEMENT ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. 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 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21323983 ↗
  • MalfunctionJan 17, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE DEVICE WAS HEATING UP. THERE WAS NO PROCEDURE NOR 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21179145 ↗
  • MalfunctionDec 27, 2024Break; Excessive Heating; Break; Excessive Heating

    IT WAS REPORTED FROM TAIWAN THAT THE ATTACHMENT ASSEMBLY WAS HOT. IT WAS NOTED THAT THE INNER BEARING WAS DAMAGED. 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 2024. 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 21027078 ↗
  • MalfunctionNov 20, 2024Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT DURING SPINAL FUSION PROCEDURE, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE GOT EXTREMELY HOT THAT IT BURNED THE TISSUE IN PATIENT'S INCISION. IT WAS UNKNOWN WHETHER TREATMENT WAS REQUIRED AFTER IRRIGATING AND CLOSING OF THE INCISION. THE STATUS OF THE PATIENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

    MAUDE report 20734446 ↗
  • InjuryNov 15, 2024Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT DURING SPINAL FUSION PROCEDURE, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE GOT EXTREMELY HOT THAT IT BURNED THE TISSUE IN PATIENT'S INCISION. IT WAS UNKNOWN WHETHER TREATMENT WAS REQUIRED AFTER IRRIGATING AND CLOSING OF THE INCISION. THE STATUS OF THE PATIENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: Burn(s)

    MAUDE report 20694205 ↗
  • MalfunctionNov 14, 2024Fail-Safe Problem; Complete Loss of Power; Fail-Safe Problem; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE RAN IN THE LOCKED POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CUTTER ENGAGEMENT AND CUTTER BRAKE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT FUNCTION. 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 20682048 ↗
  • MalfunctionOct 14, 2024Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE OVERHEATED AND DID NOT WORK. 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 20439607 ↗
  • MalfunctionSep 20, 2024Excessive Heating; Excessive Heating

    REPORT 3 OF 5 FOR THIS EVENT IT WAS REPORTED FROM JAPAN THAT THE MEDIUM ATTACHMENT DEVICE GENERATED HEAT ALONG WITH TWO OTHER MEDIUM ATTACHMENT DEVICES AND TWO SHORT ATTACHMENT DEVICES. 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 20265139 ↗
  • MalfunctionSep 20, 2024Excessive Heating; Excessive Heating

    REPORT 2 OF 5 FOR THIS EVENT. IT WAS REPORTED FROM JAPAN THAT THE MEDIUM ATTACHMENT DEVICE GENERATED HEAT ALONG WITH TWO OTHER MEDIUM ATTACHMENT DEVICES AND TWO SHORT ATTACHMENT DEVICES. 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 20265136 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133604. One submission often covers many models, so check the product and lot details in each record.

  • 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-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-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-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-0924-2023 · Dec 7, 2022 · Open, Classified
    Pediatric Craniotome Ref:CRANI-P-G1
  • 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-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-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-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-2253-2016 · Jun 15, 2016 · Terminated
    Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
  • Z-1037-2015 · Dec 10, 2014 · Terminated
    16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1

Other MOTOR, DRILL, ELECTRIC devices

All MOTOR, DRILL, ELECTRIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.