Arthrex® AR-9145-42NLRecalls & reported problems
Arthrex, Inc. · PERIPHERAL SCREW, NL, UNI REV, 4.5x42mm · 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 00888867135918), received between Jun 5, 2019 and Jun 5, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2019Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE FOLLOWING OCCURRED DURING A REVISION PROCEDURE TO REMOVE A COMPETITOR¿S DEVICE (ARTHROSURFACE HEMI CAP). AFTER REMOVAL OF THE COMPETITOR¿S DEVICE A REVERSE TOTAL SHOULDER PROCEDURE WAS THEN PERFORMED. DURING THE PROCEDURE AN ARTHREX AR-1999HH (RATCHETING HANDLE), LOT 8001640 WAS NOT RATCHETING CORRECTLY AND COULD NOT BE USED. WHILE BEING USED TO INSERT A CENTRAL SCREW, AN AR-9545-T15-03 (DRIVER SHAFT), LOT 8001643, TIP BROKE OFF IN THE HEAD OF THE SCREW. THE TIP WAS NOT RETRIEVED AND IT REMAINS IN THE SCREW IN THE PATIENT. AN AR-9545-T15-02, (DRIVER SHAFT), LOT 8001819, WAS ALSO USED AND IT WAS REPORTED THAT THE THREADS OF THE DRIVER WERE TWISTED WHEN TIGHTENING THE SUPERIOR SCREW. THE SUPERIOR PERIPHERAL SCREW AR-9145-42NL, LOT UNKNOWN, SNAPPED OFF AT THE SHAFT AND HALF OF THE SCREW WAS LEFT IN THE PATIENT UNRETRIEVED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8670909 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
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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