Arthrex® AR-18716-09Recalls & reported problems
Arthrex, Inc. · Low Profile Screw, 1.6 x 9mm, Cortical · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867313217), received between Jan 26, 2021 and Jun 13, 2022 — classified as 1 injury, 2 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 18, 2026.
Most reported problems
Device problems
- Break3
Patient problems
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2022Break
ON 5/25/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18716-09 CORTICAL SCREW HEAD BROKE OFF WHILE BEING INSERTED INTO THE AR-18714P-10 PLATE. THE HEAD WAS REMOVED FROM INSIDE THE PATIENT, HOWEVER, THE BODY OF THE SCREW REMAINS IMPLANTED. THIS WAS DISCOVERED DURING A 2ND METACARPAL BASE FRACTURE PROCEDURE ON (B)(6) 2022.
Patient problems: Foreign Body In Patient
MAUDE report 14674434 ↗MalfunctionNov 30, 2021Break
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18716-08, AN AR-18716-09, AND AN AR-18716-11 CORTICAL SCREWS BROKE ON THE FILE TIGHTENING OF THE SCREW. THIS WAS DISCOVERED DURING A PROCEDURE, THE SCREWS REMAIN INSIDE THE PATIENT. ADDITIONAL INFORMATION REQUESTED: AFTER RECEIVING ADDITIONAL INFORMATION ON 11/12/2021, SALES REPRESENTATIVE HAS CONFIRMED THAT DURING THE METACARPAL FRACTURE PROCEDURE, THREE CORTICAL SCREW BROKE AND REMAINED IN PATIENT. SURGEON USED A 1.2MM DRILL BIT TO PREPARE BONE TUNNELS AND PUT IN NEW SCREWS IN OTHER HOLES OF THE PLATE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12897489 ↗InjuryJan 26, 2021Break
IT WAS REPORTED THAT THE HEAD OF THE SCREW BROKE OFF AT THE FINAL TURN DURING A METACARPAL FRACTURE THE REMAINDER OF THE SCREW REMAINS IN THE PATIENT; FEMALE 20'S.
Patient problems: Foreign Body In Patient
MAUDE report 11231226 ↗
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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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