Arthrex® AR-9165-20NLRecalls & reported problems
Arthrex, Inc. · CENTRAL SCREW, NL, UNI REV, 6.5x20mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867136670), received between Jan 2, 2024 and Jan 2, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
- Positioning Failure1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2024Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth; Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT DURING AN INVERSE PROSTHESIS SURGERY THE SCREWS AR-9145-30 (LOT: 22.02176) AND AR-9165-20NL (LOT: 15019430) COULD NOT BE TIGHTENED WHEN THE BASE PLATE AR-9120-02 (LOT: 22.03081) AND THE GLENOSPHERE AR-9504M-04 (LOT: 22.02710) WERE IMPLANTED. AS A RESULT, THE GLENOID DID NOT HOLD AND HAD TO BE REMOVED AGAIN. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE. A SECOND SURGERY WAS REQUIRED ON THE (B)(6) 2023. UPDATE AVOE 07-DEC-2023, IT WAS CONFIRMED THAT THE SECOND SURGERY WAS REQUIRED DUE TO THE FAILURE OF THE SCREWS, WHICH DIDN`T LOCK LIKE NORMALLY.
Patient problems: Failure of Implant
MAUDE report 18429260 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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