5 POUND SHOT WEIGHT 351Recalls & reported problems
Mizuho Orthopedic Systems, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842430111693), received between Mar 1, 2022 and Mar 1, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Device Unsafe to Use in Environment1
- Device-Device Incompatibility1
- Inadequate or Insufficient Training1
- Unintended Movement1
- Use of Device Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2022Inadequate or Insufficient Training; Use of Device Problem; Device Markings/Labelling Problem; Device Unsafe to Use in Environment; Device-Device Incompatibility; Unintended Movement; Inadequate or Insufficient Training; Use of Device Problem; Device Markings/Labelling Problem; Device Unsafe to Use in Environment; Device-Device Incompatibility; Unintended Movement
PATIENT HAD LOWER LIMB TRACTION. PREPARING TO TRANSPORT FOR MRI IMAGING, STAFF DISCONNECTED THE TRACTION AND LAID THE WEIGHT BAG ON THE BED BY HIS FEET. EVERYONE ASSUMED IT WAS A SANDBAG. THE FACILITY HAD BOTH SAND BAG WEIGHTS AND IRON SHOT WEIGHTS AND GENERALLY DIDN'T DIFFERENTIATE. THE WEIGHT BAG WAS MORE THAN TEN YEARS OLD AND THE TAG INDICATING THAT IT WAS FILLED WITH METAL SHOT HAD CURLED SO IT WAS NOT READILY VISIBLE. THE HANDHELD FERROMAGNETIC SCANNER USED ON THE WEIGHT BAG'S BRASS GROMMET DID NOT ALARM, SO THE BAG WAS ALLOWED TO ENTER THE ROOM. AS THEY APPROACHED THE MAGNET, THE GURNEY WAS PULLED OUT OF THEIR HANDS AND TOWARD THE MAGNET. THE BAG SLID ALONG THE BED AND UP UNDER THE PATIENT, CAUSING PAIN BUT NO WORSENING OF THE INJURY. STAFF QUENCHED THE MAGNET TO RELEASE IT.
Patient problems: Pain
MAUDE report 13636745 ↗
Other Apparatus, Traction, Non-Powered devices
- Arthrex® AR-1600MArthrex, Inc. · Apparatus, traction, non-powered21 reports
- Active Heel Traction Boot 72203270Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED20 reports
- NA 357.371Synthes GmbH · APPARATUS, TRACTION, NON-POWERED16 reports
- NA SD393.640Synthes GmbH · APPARATUS, TRACTION, NON-POWERED15 reports
- NA 394.44Synthes GmbH · APPARATUS, TRACTION, NON-POWERED12 reports
- Arthrex® AR-8970JDArthrex, Inc. · Apparatus, traction, non-powered10 reports
- Active Heel Traction Boot 72202682Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED10 reports
- NA 72201725Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED8 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page