NA 323.046Recalls & reported problems
Synthes GmbH · 2.0MM WIRE SLEEVE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982190666), received between Aug 7, 2024 and Aug 7, 2024 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEMS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.0MM WIRE SLEEVE. THIS IS REPORT 2 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929077 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEMS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.0MM WIRE SLEEVE. THIS IS REPORT 1 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929076 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEMS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.0MM WIRE SLEEVE. THIS IS REPORT 6 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929073 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEMS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.0MM WIRE SLEEVE. THIS IS REPORT 7 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929071 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT ON JULY 14, 2024, THE ITEMS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.0MM WIRE SLEEVE. THIS IS REPORT 3 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929070 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEMS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.0MM WIRE SLEEVE. THIS IS REPORT 5 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929069 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEMS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.0MM WIRE SLEEVE. THIS IS REPORT 4 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929068 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEMS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.0MM WIRE SLEEVE. THIS IS REPORT 9 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929065 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEMS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.0MM WIRE SLEEVE. THIS IS REPORT 8 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929062 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEMS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.0MM WIRE SLEEVE. THIS IS REPORT 10 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929060 ↗
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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