Arthrex® AR-13200ST-07.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867009622), received between Jul 25, 2017 and Jun 7, 2024 — classified as 1 injury, 2 malfunctions.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED ON 09/12/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-13200ST-07.5 OSTEOTOMY PLATE BUSHING POPPED OFF AND THE SURGEON WAS UNABLE TO USE THE AR-13380-46 SCREW IN THE PROCEDURE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482526 ↗
• MalfunctionOct 4, 2022Premature Separation

  ON (B)(6) 2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT THE BUSHING OF AN AR-13200ST-07.5 PLATE POPPED OFF WHEN AN AR-13380-46 CORTICAL SCREW WAS BEING INSERTED. THE SCREW WAS NOT ABLE TO BE USED AND A LARGER SCREW WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535244 ↗
• InjuryJul 25, 2017Patient-Device Incompatibility

  IT WAS REPORTED, THAT PATIENT HAD A TIBIAL OSTEOTOMY PLATE PROCEDURE ON (B)(6) 2017. AFTER THE INITIAL PROCEDURE, THE PATIENT STARTED HAVING AN ALLERGIC REACTION BETWEEN TWO - TWO AND HALF MONTHS AFTER. PATIENT EXPERIENCED HIVES ALL OVER THE BODY. PATIENT THEN REACHED OUT TO THE SURGEON WHO PERFORMED THE PROCEDURE. ON (B)(6) 2017, PATIENT HAD A CONSULTATION WITH THE SURGEON, WHICH PRESCRIBED ANTIBIOTIC BECAUSE IT APPEAR TO BE AN INFECTION. THE ANTIBIOTICS DIDN'T WORK SO SURGEON SUGGESTED FOR THE PATIENT TO SEE A DERMATOLOGY SPECIALIST. THE PATIENT THEN SAW A DERMATOLOGY SPECIALIST AT THE UNIVERSITY (B)(6); WHERE THE PATIENT WAS TESTED FOR A STAPH INFECTION. THE BIOPSY RESULTS CAME BACK NEGATIVE. APPROXIMATELY THE SECOND OR THIRD WEEK IN (B)(6), PATIENT SAW ANOTHER DERMATOLOGY SPECIALIST. THE DERMATOLOGIST PRESCRIBED SOME CREAM TO APPLY ON THE BODY. PATIENT DESCRIBED THAT THE CREAM PRESCRIBED HELPS AT TIMES BUT IS STILL HAVING A REACTION AND HIVES WILL NOT GO AWAY. THE PATIENT HAS INDICATED THAT A STAPLE AND TWO SCREWS FROM TWO OTHER MANUFACTURERS WERE ALSO IMPLANTED IN THE KNEE DURING THE INITIAL PROCEDURE.

  Patient problems: Inadequate Pain Relief; Reaction; Urticaria

  MAUDE report 6740960 ↗