Arthrex® AR-13200MRecalls & reported problems
Arthrex, Inc. · PLT,LO-PRO,FLAT TI · 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 00888867008922), received between Aug 26, 2019 and Aug 26, 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
- Loose or Intermittent Connection1
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.
InjuryAug 26, 2019Break; Loose or Intermittent Connection
IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A LEFT FOOT TENDON REPAIR WITH BONE MARROW ASPIRATION ON (B)(6) 2019. DURING THE PROCEDURE THE PATIENT STATES THAT AN ARTHREX L-PLATE AND SCREWS WERE IMPLANTED ALONG WITH A WEDGE AND GRAFT. PATIENT STATED ONE OF THE SCREWS HAS BROKEN, LEAVING THE TOP PORTION LOOSE IN THE FOOT. PATIENT IS HAVING TREMENDOUS PAIN AND THE BREAKAGE WILL RESULT IN NEEDING A SECOND PROCEDURE. THE PATIENT ONLY HAD TWO OF THE SCREW PART NUMBERS AT TIME OF REPORT, AR-8724-16 (QTY 1) AND AR-8724-14 (QTY 2). IT IS UNKNOWN IF ONE OF THESE TWO SCREWS MAY BE THE BROKEN ONE OF IF THERE MAY BE OTHER SCREWS THAT WERE ALSO IMPLANTED PATIENT WILL REACH OUT TO THE SURGICAL FACILITY TO OBTAIN THE IMPLANT LOG AND PROVIDE TO ARTHREX UPON RECEIPT. PATIENT ALSO REPORTED THAT SHE HAD ROLLED HER ANKLE AT HER HOME (RENTAL) AND REPORTED IT TO HER LANDLORD AND REPORTED THE NOW DISCOVERED BROKEN SCREW ISSUE. LANDLORD STANCE ON THE ISSUE WAS THAT ROLLING HER ANKLE SHOULD NOT CAUSE THE SCREW TO BREAK BECAUSE TITANIUM SHOULD NOT BREAK, LANDLORD INSTRUCTED PATIENT TO CONTACT THE MANUFACTURER (ARTHREX). UPDATED INFORMATION OBTAINED 7/22/2019: PATIENT IS STILL ATTEMPTING TO OBTAIN THE R
Patient problems: Failure of Implant
MAUDE report 8930593 ↗
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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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