NA 05.001.212Recalls & reported problems
Synthes GmbH · QUICK COUPLING FOR K-WIRES FOR TRAUMA RECON SYSTEM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes quick coupling for K-wires is a powered attachment that holds thin surgical wires. Many of the 181 reports describe jamming, loss of power or overheating, often found during repair checks rather than surgery. The reports include 181 malfunctions, no injuries and no deaths. Reports from the last 12 months number 7, compared with 22 in the 12 months before. 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
- 183
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 10886982129796), received between Feb 13, 2018 and Sep 29, 2026 — classified as 183 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (85 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam85
- Complete Loss of Power70
- Excessive Heating51
- Appropriate Device Problem Term/Code Not Available21
- Compatibility Problem12
- Device-Device Incompatibility12
- Detachment of Device or Device Component11
- Noise, Audible7
Patient problems
- No Clinical Signs, Symptoms or Conditions159
- No Consequences Or Impact To Patient17
- No Known Impact Or Consequence To Patient7
Recent adverse event reports
The 25 most recent of 183 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Excessive Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938285 ↗MalfunctionSep 11, 2026Mechanical Jam; Complete Loss of Power
It was reported that during service and evaluation, it was determined that the quick coupling device was frozen/would not move. It was noted in the service order that the device did not move. 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 50733714 ↗MalfunctionJul 27, 2026Mechanical Jam; Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50034828 ↗MalfunctionMay 1, 2026Compatibility Problem
IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE QUICK COUPLING DEVICE DAMAGED OR BROKE THE K WIRE. 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 25057016 ↗MalfunctionApr 29, 2026Noise, Audible; Excessive Heating
IT WAS REPORTED THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE WAS MAKING A STRANGE NOISE AND WAS OVERHEATING. 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 25029709 ↗MalfunctionApr 27, 2026Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING FOR K-WIRES FOR TRS DEVICE FELL APART. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS SPOILED. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. 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 24999017 ↗MalfunctionFeb 23, 2026Compatibility Problem; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING ATTACHMENT DEVICE WOULD DAMAGE/BREAK K-WIRE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 24419330 ↗MalfunctionJan 6, 2026Mechanical Jam; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WAS FROZEN/WILL NOT MOVE AND HAD COSMETIC DAMAGE. IT WAS NOTED THAT THE DEVICE DID NOT WORK, AND THE SLEEVE PIN WAS LONG. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK PINS LENGTH OF HANDPIECE COUPLING CONE SLEEVE AND CHECK FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. 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 2025. 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 23973390 ↗MalfunctionNov 21, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION IN RUNNING MODE. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23621999 ↗MalfunctionOct 28, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING POST-SURGERY, IT WAS DISCOVERED THAT THE QUICK COUPLING FOR K-WIRE DEVICE HAD INTERMITTENT RELEASE OF PIN. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23403890 ↗MalfunctionOct 21, 2025Complete Loss of Power; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING FOR K-WIRES DEVICE HAD COSMETIC DAMAGE - THE ETCHING WAS WORN, WAS FROZEN/WOULD NOT MOVE, WAS CORRODED/RUSTED/PITTING AND WOULD NOT HOLD K-WIRE DEVICE. THE DEVICE ALSO FAILED PRETESTS FOR GENERAL CONDITION, MARKINGS, CHECK CANNULATION OF ATTACHMENT AND CHECK TOOL QUICK COUPLING. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. 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 23347761 ↗MalfunctionOct 20, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WAS FROZEN/WOULD NOT MOVE AND THE K-WIRE SETTING COULD NOT BE CHANGED. THE DEVICE ALSO FAILED PRETESTS FOR CHECK FUNCTION OF ADJUSTING SLEEVE AND CHECK TOOL QUICK COUPLING. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. 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 23335687 ↗MalfunctionJul 29, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power
IT WAS REPORTED THAT THE QUICK COUPLING FOR K-WIRE DEVICE DID NOT WORK. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS FROZEN/WOULD NOT MOVE, WOULD NOT HOLD K-WIRE AND HAD COSMETIC DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE TOOL QUICK COUPLING AND CHECK FUNCTION IN RUNNING MODE. 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 22643176 ↗MalfunctionJul 29, 2025Detachment of Device or Device Component; Complete Loss of Power; Detachment of Device or Device Component; Complete Loss of Power
IT WAS REPORTED THAT THE QUICK COUPLING FOR K-WIRE DEVICE WAS NOT WORKING. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE FELL APART-UNATTACHED AND WOULD NOT HOLD K-WIRE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FUNCTION OF ADJUSTING SLEEVE AND CHECK THE TOOL QUICK COUPLING. 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 22642136 ↗MalfunctionJul 8, 2025Detachment of Device or Device Component; Complete Loss of Power; Detachment of Device or Device Component; Complete Loss of Power
IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WOULD NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE FELL APART ¿ UNATTACHED. 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 22436782 ↗MalfunctionJul 3, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE WIRE ATTACHMENT WAS NOT PROPERLY AND HEATED UP AFTER A SHORT TIME. THE EVENT DID NOT OCCUR DURING 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394256 ↗MalfunctionJul 2, 2025Device-Device Incompatibility; Excessive Heating; Device-Device Incompatibility; Excessive Heating
IT WAS REPORTED THAT THE QUICK COUPLING DEVICE OVERHEATED AND WOULD NOT HOLD THE K-WIRE. 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. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382434 ↗MalfunctionJun 11, 2025Excessive Heating; Excessive Heating
THIS IS REPORT 4 OF 4 FOR THE SAME EVENT. IT WAS REPORTED THAT THE BATTERY HANDPIECE DEVICE, CHUCK DEVICE, AND TWO (X2) QUICK COUPLING DEVICES HAVE HEAT WHILE IN USE. 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. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22187351 ↗MalfunctionJun 6, 2025Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Mechanical Jam; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS SPOILED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS FROZEN/WILL NOT MOVE, THE ETCHING WAS ILLEGIBLE, THE DEVICE COULD NOT ENGAGE THE ATTACHMENT ¿ COUPLING. IT WAS NOTED THAT THE ATTACHMENT MARKING FADED, FAILED PIN LENGTH TEST, AND WILL NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING AND LABELING, CHECK PINS LENGTH OF HANDPIECE COUPLING CONE SLEEVE, AND CHECK FUNCTION IN RUNNING MODE. 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 22161171 ↗MalfunctionMay 15, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER WASHING THE QUICK COUPLING FOR K-WIRE DEVICE AND DURING THE DRYING PROCESS, IT WAS OBSERVED THAT DARK LIQUID RAN FROM INSIDE THE 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22026319 ↗MalfunctionMay 1, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS LEAKING OIL. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF DELAYS IN THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21945327 ↗MalfunctionApr 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS LEAKING OIL. 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 21890839 ↗MalfunctionMar 31, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS DETERMINED THAT THE DEVICE HAD COSMETIC DAMAGE - WORN ETCH, COSMETIC DAMAGE ¿ WORN, COULD NOT ENGAGE THE ATTACHMENT ¿ COUPLING, WOULD NOT HOLD THE K-WIRE AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECK THE TOOL QUICK COUPLING, CHECK SELF-HOLDING FORCE IN SMALLEST RANGE AND CHECK FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 21732287 ↗MalfunctionMar 26, 2025Physical Resistance/Sticking; Excessive Heating; Physical Resistance/Sticking; Excessive Heating
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE HAD HEAT AND FAILED PRE-TEST FOR CHECK FUNCTION IN THE RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE K WIRE ATTACHMENT IS WORKING GOOD BUT COMPLAINT IS WHILE RUNNING TIME THE K WIRE SIZE AUTOMATICALLY CHANGES TO ANOTHER SIZE. 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 21696357 ↗MalfunctionMar 4, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING FOR K-WIRE DEVICE WAS FROZEN/WOULD NOT MOVE AND HAD COSMETIC DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK PINS LENGTH OF HANDPIECE COUPLING CONE SLEEVE AND CHECK FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 (B)(6) 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21514671 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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