NA 03.111.014Recalls & reported problems
Synthes GmbH · JOINT PREP/CARTILAGE REMOVER 20 DEG BEND/12MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982072139), received between Jul 30, 2020 and Nov 1, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE SURGERY THE INSTRUMENT BROKE. THERE WAS NO REPORTED SURGICAL DELAY. THE FRAGMENTS WERE EASILY REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) JOINT PREP/CARTILAGE REMOVER 20 DEG BEND/12MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18046696 ↗MalfunctionMay 27, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE JOINT PREP/CARTILAGE REMOVER WAS BROKEN. THERE WAS NO KNOWN PATIENT OR SURGICAL IMPACT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) JOINT PREP/CARTILAGE REMOVER 20 DEG BEND/12MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11894190 ↗MalfunctionJul 30, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020, THE JOINT PREP/CARTILAGE REMOVER BROKE DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) CALCANEAL FRACTURE PROCEDURE. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10344023 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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