Arthrex® AR-1938DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867024212), received between Feb 17, 2017 and Feb 17, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 17, 2017Metal Shedding Debris

  IT WAS REPORTED THAT TWO 2.6MM DRILLS FOR 3MM SUTURETAK (AR-1938D) ALONG WITH ONE 3MM SUTURETAK PERCUTANEOUS INSERTION KIT (CC104986 LINE181875 AR-1934PI-30) AND ONE TROCAR TIP OBTURATOR FOR 3MM SUTURETAK DISPOSABLE SPEAR (CC104986 LINE 181877 AR-1949S) WERE BEING USED IN A SHOULDER LABRAL REPAIR PROCEDURE. WHILE USING THE FIRST DRILL (CC104986 LINE 181872) WITH A COMPETITORS DEVICE SET AT FULL SPEED ALONG WITH THE DRILL GUIDE FROM AR-1934PI-30 (CC104986 LINE 181875), IT WAS NOTICED THAT THERE WERE METAL SHAVINGS BEING PRODUCED INSIDE THE PATIENT. AN ATTEMPT WAS MADE TO REMOVE THE METAL SHAVINGS FROM THE PATIENT BY USING A FRAZIER TIP SUCTION DEVICE AND HIGH FLOW SHAVER. THE SURGEON WAS UNABLE TO RETRIEVE ALL SHAVINGS. THE SECOND DRILL (CC104986 LINE181874) WAS USED WITH A COMPETITORS DEVICE, ALONG WITH THE DISPOSABLE SPEAR (CC104986 LINE 181877) AND ALSO PRODUCED METAL SHAVINGS. THE SAME TECHNIQUE WAS USED AGAIN TO TRY AND REMOVE THE METAL SHAVINGS, AND AGAIN ALL OF THE SHAVINGS WERE UNABLE TO BE RETRIEVED FROM THE PATIENT. SALES REP STATED THE SURGEON MENTIONED THAT SHE BELIEVES THE METAL SHAVINGS WERE CREATED BY THE DRILL AND DRILL GUIDE COMING IN CONTACT WITH EACH OTHER. A REUS

  Patient problems: No Information

  MAUDE report 6338830 ↗
• InjuryFeb 17, 2017Material Fragmentation

  IT WAS REPORTED THAT TWO 2.6MM DRILLS FOR 3MM SUTURETAK (AR-1938D) ALONG WITH ONE 3MM SUTURETAK PERCUTANEOUS INSERTION KIT (CC104986 LINE181875 AR-1934PI-30) AND ONE TROCAR TIP OBTURATOR FOR 3MM SUTURETAK DISPOSABLE SPEAR (CC104986 LINE 181877 AR-1949S) WERE BEING USED IN A SHOULDER LABRAL REPAIR PROCEDURE. WHILE USING THE FIRST DRILL (CC104986 LINE 181872) WITH A COMPETITORS DEVICE SET AT FULL SPEED ALONG WITH THE DRILL GUIDE FROM AR-1934PI-30 (CC104986 LINE 181875), IT WAS NOTICED THAT THERE WERE METAL SHAVINGS BEING PRODUCED INSIDE THE PATIENT. AN ATTEMPT WAS MADE TO REMOVE THE METAL SHAVINGS FROM THE PATIENT BY USING A FRAZIER TIP SUCTION DEVICE AND HIGH FLOW SHAVER. THE SURGEON WAS UNABLE TO RETRIEVE ALL SHAVINGS. THE SECOND DRILL (CC104986 LINE181874) WAS USED WITH A COMPETITORS DEVICE, ALONG WITH THE DISPOSABLE SPEAR (CC104986 LINE 181877) AND ALSO PRODUCED METAL SHAVINGS. THE SAME TECHNIQUE WAS USED AGAIN TO TRY AND REMOVE THE METAL SHAVINGS, AND AGAIN ALL OF THE SHAVINGS WERE UNABLE TO BE RETRIEVED FROM THE PATIENT. SALES REP STATED THE SURGEON MENTIONED THAT SHE BELIEVES THE METAL SHAVINGS WERE CREATED BY THE DRILL AND DRILL GUIDE COMING IN CONTACT WITH EACH OTHER. A REUS

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6338826 ↗