NA 1806-0238Recalls & reported problems
Stryker GmbH · Screwdriver, Self-Holding, Short · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540520432), received between Dec 9, 2019 and Jul 25, 2023 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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.
Most reported problems
Device problems
- Fracture4
- Break2
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2023Break; Fracture; Break; Fracture
AS REPORTED: "THE UPPER PART OF THE SCREWDRIVER IS BROKEN OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17393972 ↗MalfunctionDec 8, 2022Break; Fracture; Break; Fracture
AS REPORTED: "ONE SMALL TOOTH BROKEN OFF SCREWDRIVER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15947175 ↗MalfunctionDec 2, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE SCREWDRIVER AND SLEEVE STRIPPED THE HEAD OF A GAMMA SCREW.
Patient problems: Insufficient Information
MAUDE report 15901400 ↗InjuryOct 28, 2020Fracture; Fracture
CASE HAS OCCURRED DURING A G3 SURGERY. WHEN LOCKING THE DISTAL 5MM SCREW, HALF OF THE HEX WAS BROKEN OFF THE SELF-HOLDING SCREWDRIVER. THIS EVENT WAS NOT DETECTED DURING SURGERY. ONLY ONE DAY LATER IN THE CONTROL X-RAY IT WAS SEEN THAT PART OF THE SCREWDRIVER WAS INSIDE THE PATIENT. THE PATIENT WAS RE-OPERATED ON (B)(6) 2020 AND THE BROKEN PART WAS REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 10748699 ↗MalfunctionDec 9, 2019Fracture; Fracture
THE TIP OF THE SCREWDRIVER BROKE. IT WAS NOTICED DURING INSTRUMENT PREPARATION.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9441239 ↗
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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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