Arthrex® AR-8840CL-50Recalls & reported problems
Arthrex, Inc. · LOW PROF SCRW,SS 4.0X 50MMCANN LNG THD · Class 2 · Implant
Data updated Oct 16, 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 00888867048256), received between Oct 11, 2019 and Oct 11, 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 16, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2019Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANKLE FRACTURE LATERAL MALLEOLUS PROCEDURE THE HEAD OF THE AR-8840CL-50 LOW PROFILE SCREW BROKE OFF ONCE THE BODY OF THE SCREW WAS IN THE PATIENT. THE REP STATED THE HEAD OF THE SCREW WAS RETRIEVED, BUT THE BODY OF THE SCREW REMAINS IN THE PATIENT. IT WAS REPORTED THAT THE BODY OF THE SCREW WAS STILL ACTING AS A LATERAL AND MEDIAL STABILIZER, AND EVEN THOUGH THE SCREW WAS NO LONGER APPLYING COMPRESSION IT STILL SERVED ITS PURPOSE. THERE WERE NO ATTEMPTS MADE TO REMOVE THE BODY OF THE SCREW. THE REP REPORTED A SECOND SURGERY IS NOT NECESSARY. ADDITIONAL INFORMATION RECEIVED ON 09/23/2019: THE REP STATED THERE IS NOT A LOT NUMBER PHYSICALLY LOCATED ON THE AR-8840CL-50, BUT THE REP BELIEVES THE SCREW IS FROM LOT: W627551. THE RETRIEVED HEAD OF THE SCREW IS AVAILABLE TO RETURN FOR EVALUATION. THE IMPLANT WAS BEING PLACED INTO THE MEDIAL MALLEOUS. NO GRAFT WAS USED. THE BONE QUALITY WAS MEDIUM TO HARD. NO UNPLANNED INCISIONS WERE NECESSARY. A 3.0 DRILL BIT WAS USED TO PREPARE THE BONE. THE REP REPORTED THERE WAS NO ATTEMPT TO REMOVE THE SCREW BECAUSE IT WAS STILL ACTING AS A LATERAL AND MEDIAL STABILIZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9178721 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page