Arthrex® AR-1999SDRecalls & reported problems
Arthrex, Inc. · SLAPDRIVER, RATCHETING QUICK CONNECT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867351301), received between Jun 10, 2024 and Jun 10, 2024 — classified as 4 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. 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
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2024Break; Break
ON 5/12/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-1999SD RATCHETING HANDLE SLAPDRIVER BROKE DURING A PROCEDURE. NOTHING BROKE INSIDE THE PATIENT. THE HANDLE BECAME FIXED, AND THE SHAFT BROKE. THIS WAS DISCOVERED DURING A PROCEDURE; THE DATE IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19505409 ↗MalfunctionJun 10, 2024Break; Break
ON 5/19/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-1999SD RATCHETING HANDLE SLAP DRIVER BROKE DURING A PROCEDURE. NOTHING BROKE INSIDE THE PATIENT. THE HANDLE BECAME FIXED, AND THE SHAFT BROKE. THIS WAS DISCOVERED DURING A PROCEDURE, DATE IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19505350 ↗MalfunctionJun 10, 2024Break; Break
ON 5/19/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-1999SD RATCHETING HANDLE SLAPDRIVER BROKE DURING A PROCEDURE. NOTHING BROKE INSIDE THE PATIENT. THE HANDLE BECAME FIXED, AND THE SHAFT BROKE. THIS WAS DISCOVERED DURING A PROCEDURE; THE DATE IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19500121 ↗MalfunctionJun 10, 2024Break; Break
ON 5/19/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-1999SD RATCHETING HANDLE SLAPDRIVER BROKE DURING A PROCEDURE. NOTHING BROKE INSIDE THE PATIENT. THE HANDLE BECAME FIXED, AND THE SHAFT BROKE. THIS WAS DISCOVERED DURING A PROCEDURE; THE DATE IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19500081 ↗
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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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