Arthrex® AR-7000-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867041073), received between Dec 14, 2020 and Aug 24, 2021 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2021Break

  DURING A LATARJET PROCEDURE THE SURGEON WAS TIGHTENING THE SCREW (AR-7000-36) AND THE HEAD SNAPPED OFF. NO INJURY. AN ADDITIONAL SCREW WAS PLACED TO COMPENSATE FROM LOSS OF COMPRESSION FROM BROKEN SCREW. SURGEON HAD PREDRILLED THE HOLE WITH THE AR-7000-14 DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362183 ↗
• InjuryDec 14, 2020Break; Unstable; Device Dislodged or Dislocated; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING AN (B)(6) 2020 LATARJET PROCEDURE ON REVISION CASE WITH BONE LOSS, THE SURGEON SIZED, SHAPED, AND DRILLED TWO 1.6 K WIRES INTO THE CORACOID GRAFT. USING THE 2.75 CANNULATED DRILL, TUNNELS WERE DRILLED TO THE APPROPRIATE DEPTHS FOR EACH 3.75MM FULLY THREADED SCREW. THE FIRST SCREW WAS PLACED OVER THE K WIRE AND DRILLED WITH POWER DOWN TO ABOUT 5 MILLIMETERS SHY OF COMPRESSION. A HAND SCREWDRIVER WAS THEN USED TO TIGHTEN THE SCREW. AFTER 3 TURNS, THE HEAD SHEARED OFF AND LEFT ABOUT 4 MILLIMETERS OF SCREW SHAFT PROTRUDING FROM THE CORACOID GRAFT WITH ZERO COMPRESSION. THE SCREW HEAD WAS ABLE TO BE REMOVED FROM THE K WIRE AND OUT OF THE PATIENT. THE SURGEON INSERTED THE 2ND SCREW BY DRILLING TO A SIMILAR DEPTH, SLIGHTLY SHY OF ANY COMPRESSION. THE HAND SCREWDRIVER WAS USED AND ADEQUATE COMPRESSION WAS PROVIDED FOR SCREW NUMBER TWO. A PAIR OF NEEDLE-NOSED PLIERS WAS OPENED TO TRY AND REMOVE THE FIRST SCREW¿S SHAFT FROM THE GLENOID. THE ATTEMPT WAS UNSUCCESSFUL. THE REMNANTS OF THE SCREW HEAD AND FRAGMENTS WERE DISCARDED BY THE SCRUB TECH ON THE BACK TABLE. THE PATIENT WAS ASSESSED AND THE SHOULDER DID NOT DISLOCATE OR HAVE MUCH TRANSLATION. THE SURGEON CONSID

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11004109 ↗