Arthrex® AR-1201-7DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867003941), received between Mar 5, 2019 and Mar 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2019Break; Loose or Intermittent Connection

  IT WAS REPORTED BY THE PATIENT¿S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A LEFT 1ST METATARSOPHALANGEAL JOINT REVISION FUSION AND HARDWARE REMOVAL, EXTRACTION OF GRAFT AND WEIL OSTEOTOMY ON (B)(6) 2017 DUE TO PAINFUL NONUNION OF HER LEFT FIRST METATARSOPHALANGEAL JOINT FUSION. DURING THE PROCEDURE THE SURGEON EXPLANTED A PLATE AND LAG SCREWS FROM A PREVIOUS PROCEDURE (DATE OF PREVIOUS PROCEDURE AND EXPLANTED DEVICE MANUFACTURER UNKNOWN AT TIME OF INITIAL REPORT). THE SURGEON UTILIZED A 1.7 MM DRILL BIT, AR-1201-7DC, FOR MICRO DRILLING THROUGH THE FUSION SITE IN ORDER TO PROMOTE INGROWTH AND THE DRILL BIT SNAPPED OFF INTRAMEDULLARY. THE SURGEON ATTEMPTED TO REMOVE THE DRILL BIT FRAGMENT BUT WAS UNABLE TO BECAUSE OF THE LOCATION. THE OPERATIVE REPORT DATED (B)(6) 2017 NOTED THAT REMOVAL OF THE DRILL BIT FRAGMENT WOULD CAUSE MORE HARM TO THE PATIENT. THE SURGEON FINISHED THE SURGERY BY PERFORMING A CAPSULOTOMY AND WEILL OSTEOTOMY AND IMPLANTED THE FOLLOWING ARTHREX PLATE AND SCREWS: AR-8944CL-L (LOW PROFILE MTP PLATE), AR-8730-38PT (QUICKFIX SCREW), AR-8933-24 (LOW PROFILE SCREW), AR-8933-18 (LOW PROFILE SCREW), AND AR-8933L-18 (QTY 2) (LOW PROFILE LOCKING SCREW). IN (B)(6) 20

  Patient problems: Foreign Body In Patient

  MAUDE report 8391586 ↗