NA 5407-150-000Recalls & reported problems
Stryker Corporation · PI DRIVE 2 MOTOR · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327504019), received between Mar 4, 2024 and Mar 9, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Fracture3
- Excessive Heating1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A PIECE CAME OFF THE DEVICE. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24546125 ↗MalfunctionDec 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716346 ↗MalfunctionAug 13, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22792587 ↗MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22419820 ↗MalfunctionMay 20, 2025Fracture; Fracture
IT WAS REPORTED THAT A ROUTER BROKE DURING A PROCEDURE. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. INFORMATION REGARDING MEDICAL INTERVENTION AND SURGICAL DELAY HAS BEEN REQUESTED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22052818 ↗MalfunctionJul 15, 2024Sparking; Excessive Heating; Sparking; Excessive Heating
IT WAS REPORTED THAT, DURING A LATERAL INTERNAL SPHINCTEROTOMY, A COMPETITOR TIP WAS BEING USED WITH THE STRYKER E-SEP PENCIL AND THE TIP SPARKED TWICE AND BURNED THE TIP OF THE CAUTERY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19741260 ↗MalfunctionMar 4, 2024Fracture; Fracture
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THERE WAS A BROKEN BUR IN THE DEVICE WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18833555 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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