Arthrex® AR-1400TCRecalls & reported problems
Arthrex, Inc. · BIO-COMPR INTERF SCRW,FULL THD · Class 2 · Implant
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 00888867016231), received between Jan 31, 2022 and Oct 12, 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
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 12, 2023Break; Break
FURTHER INFORMATION WERE PROVIDED THAT THE SURGEON TRIED TO IMPLANT IN THE SCREW INTO THE BONE BUT THE SCREW DIDN¿T ADVANCE AND THE THREAD DIDN¿T GRIP, WHILE HE FORCED THE IMPLANT THE TIP OF THE SCREW BROKE OFF BUT IT WAS AT THE BEGINNING OF THE TIBIAL TUNNEL SO THE SURGEON WAS ABLE TO REMOVE THE FRAGMENT WITH A CLAMP.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17919824 ↗MalfunctionApr 26, 2023Break; Break
ON 03/28/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1400TC BIOCOMPOSITE INTERFERENCE SCREW BROKE. THIS OCCURRED DURING A CASE, DURING INSERTION THE SCREW WAS NOT PROGRESSING THE SURGEON INSISTED UNTIL THE SCREW BROKE AND THE KEY BENT. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16815007 ↗MalfunctionJan 31, 2022Break; Output Problem
ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1400TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW GOES IN WELL INTO THE TUNNEL; HOWEVER, WHEN REMOVING THE SCREWDRIVER, THE SCREW CAME OUT WITH IT, DAMAGED, AND WAS NOT ABLE TO USE AGAIN. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13393090 ↗
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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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