Arthrex® AR-9944S-5LRecalls & reported problems
Arthrex, Inc. · MaxForce MTP Plate, Std, 5°-5°, Left · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867345614), received between Aug 1, 2025 and Sep 2, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- Failure of Implant2
- Bone Fracture(s)1
- Malunion of Bone1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2025Break; Break
IT WAS REPORTED THAT AFTER A SURGERY ON (B)(6) 2025 THE PLATE BROKE. AN ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE PLATE AND TO REVISE THE PLATE ON (B)(6) 2025. NO FURTHER INFORMATION RECEIVED. UPDATE 18-AUG-2025: ACCORDING TO THE SURGEON, THE PATIENT HAS FOLLOWED THE POST-OPERATIVE GUIDELINES. X-RAYS ARE ALSO PROVIDED, SEE ATTACHMENTS.
Patient problems: Failure of Implant
MAUDE report 22944451 ↗InjuryAug 1, 2025Break; Break
ON 07/15/2025, A FACILITY REPRESENTATIVE REPORTED VIA EMAIL THAT THE PATIENT WAS SEVEN MONTHS POST-OPERATIVE FROM A FIRST MTP FUSION PROCEDURE USING AN AR-9944S-5L MAXFORCE MTP COMPRESSION PLATE. THE JOINT FUSION WAS UNSUCCESSFUL, AND THE PATIENT SUSTAINED STRESS FRACTURES IN BOTH THE PROXIMAL PHALANX AND THE FIRST METATARSAL. SUBSEQUENTLY, TWO SCREWS BACKED OUT, AND THE PLATE FRACTURED. THE PATIENT UNDERWENT REVISION SURGERY FOR PLATE AND SCREW REMOVAL. ADDITIONAL INFORMATION REQUESTED ON 7/22/2025.
Patient problems: Bone Fracture(s); Failure of Implant; Malunion of Bone; Nonunion/Delayed-union Bone Fracture
MAUDE report 22686259 ↗
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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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