SALVATION SB080045Recalls & reported problems
Wright Medical Technology, Inc. · Tapered Drill Bit · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889797060585), received between May 24, 2021 and Aug 15, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT WHILE DRILLING USING THE 4.3/3MM TAPER DRILL FOR A 5MM BOLT THE DRILL TIP SNAPPED ON THE TAPERED AREA WITHIN THE PATIENT. THE DRILL BIT WAS REMOVED AND THE SURGERY CONTINUED AS PLANNED SUCCESSFULLY. AN ADDITIONAL DORSAL INCISION AND CUT NEEDED TO BE CREATED. A SURGICAL DELAY OF 20 MINUTES WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22820453 ↗InjuryMay 24, 2021Break; Break
IT WAS REPORTED THAT THE STEP DRILL BIT BROKE OFF IN THE PATIENT'S METATARSAL. IT SNAPPED AT THE SITE WHERE THE STEP OF THE DRILL IS. LOCATED. THERE WAS A 20 MINUTE DELAY TO THE SURGERY AS THE SURGEON MADE A SMALL INCISION POSTERIOR NEAR THE ACHILLES TO RETRIEVE THE DRILL BIT PIECE. ALL FRAGMENTS WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11873481 ↗
Other BIT, SURGICAL devices
- Tornier Perform MWJ127Tornier, Inc. · BIT, SURGICAL114 reports
- NA 310.534Synthes GmbH · BIT, SURGICAL64 reports
- NA 4200355042Stryker Corporation · BIT, SURGICAL34 reports
- ACUFEX 72204044Smith & Nephew, Inc. · BIT, SURGICAL25 reports
- NA 03.168.011Synthes GmbH · BIT, SURGICAL20 reports
- ACUFEX 72204042Smith & Nephew, Inc. · BIT, SURGICAL19 reports
- ACUFEX 72204046Smith & Nephew, Inc. · BIT, SURGICAL16 reports
- ACUFEX 72204045Smith & Nephew, Inc. · BIT, SURGICAL14 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.
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