NA 2296033111Recalls & reported problems
Stryker Corporation · Precision (9.0 x 0.51 x 25.0mm) · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540046956), received between Mar 29, 2021 and Oct 23, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2023Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17987497 ↗MalfunctionJul 26, 2023Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17398747 ↗MalfunctionMar 29, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING A ACL PROCEDURE, THREE BLADES BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE THIRD BLADE THAT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11581381 ↗MalfunctionMar 29, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING A ACL PROCEDURE, THREE BLADES BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE SECOND BLADE THAT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11581373 ↗MalfunctionMar 29, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING A ACL PROCEDURE, THREE BLADES BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE FIRST BLADE THAT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11581372 ↗
Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices
- NA 511.801Synthes GmbH · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL223 reports
- Formula 0375544000Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL98 reports
- NA 0277096325Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL95 reports
- NA 310.25Synthes GmbH · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL91 reports
- Arthrex® AR-8400TDArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL86 reports
- NA 0277096275Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL72 reports
- Arthrex® AR-7300DSArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL70 reports
- NA 0277096277Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL69 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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