NA 312.22Recalls & reported problems
Synthes GmbH · 2.0MM/1.5MM DOUBLE DRILL SLEEVE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982187680), received between Aug 31, 2018 and Apr 14, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Material Deformation4
- Material Discolored4
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Material Discolored; Material Deformation
IT WAS REPORTED ON AN UNKNOWN DATE, IT WAS REPORTED MULTIPLE DEVICES WERE BENT AND HAD FADED HANDLES. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877031 ↗MalfunctionApr 14, 2026Material Discolored; Material Deformation
IT WAS REPORTED THAT THERE WAS A BOX DAMAGED ON TFNA NAILS, AND OTHER INSTRUMENTS NEED REPLACEMENT. ITEMS WERE BENT AND THERE WERE FADED HANDLES. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871467 ↗MalfunctionApr 14, 2026Material Discolored; Material Deformation
IT WAS REPORTED THAT THERE WAS A BOX DAMAGED ON TFNA NAILS, AND OTHER INSTRUMENTS NEED REPLACEMENT. ITEMS WERE BENT AND THERE WERE FADED HANDLES. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871455 ↗MalfunctionApr 14, 2026Material Discolored; Material Deformation
IT WAS REPORTED THAT THERE WAS A BOX DAMAGED ON TFNA NAILS, AND OTHER INSTRUMENTS NEED REPLACEMENT. ITEMS WERE BENT AND THERE WERE FADED HANDLES. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871436 ↗MalfunctionJun 28, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE 2.0MM/1.5MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 7 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17216728 ↗MalfunctionNov 17, 2020Break; Break
IT WAS REPORTED THAT DURING FOOT PROCEDURE ON (B)(6) 2020, THE 1.5MM DRILL BIT BROKE OFF IN DRILL SLEEVE. CONCOMITANT DEVICE REPORTED: 1.5MM DRILL BIT/QC/85MM (PART # 310.15, LOT # UNKNOWN, QUANTITY 1).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10852475 ↗MalfunctionDec 4, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE DRILL SLEEVE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9411041 ↗MalfunctionAug 31, 2018Break; Break
IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE ON (B)(6) 2018, THE TIP OF THE DOUBLE DRILL SLEEVE BROKE. NO PATIENT CONSEQUENCE OR SURGICAL DELAY WAS REPORTED. THIS REPORT IS FOR ONE (1) 2.0MM/1.5MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7837440 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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