Arthrex® AR-1204LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867004658), received between Oct 23, 2019 and Aug 18, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304369 ↗
• MalfunctionNov 22, 2021Contamination

  BONE WAS FOUND IN THE A 4MM CANNULATED DRILL BIT THAT WAS APART OF THE LRTI LOAN SET SENT TO TAMARA PRIVATE. THE SCRUB NURSE STUCK A WIRE UP THE DRILL BIT BEFORE IT WAS USED AND A SMALL PIECE OF BONE OR DEBRIS WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853814 ↗
• InjuryOct 23, 2019Material Fragmentation

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A LEFT SHOULDER ORIF OF DISTAL CLAVICLE FRACTURE, OPEN CORACOCLAVICULAR LIGAMENT REPAIR WITH TWIN TAIL TIGHTROPE AUGMENTATION. DURING USE OF THE 4 MM CANNULATED DRILL, AR-1204L, APPROPRIATE POSITION FOR THE MEDIAL DRILL TUNNEL ON THE CLAVICLE WAS DETERMINED, THEN DRILLED. THE REAMER HAD A SMALL BURR ON THE TIP AND AS THE SEGMENT WAS REAMED, A SMALL FRAGMENT OF THE END OF THE REAMER BROKE OFF IN THE MIDDLE OF THE CLAVICLE. THE BROKEN TIP WAS NOT IN A BAD PLACE, AND THE DECISION WAS MADE TO LEAVE IT WHERE IT WAS, AS IT WAS NOT POSSIBLE TO FISH IT OUT WITHOUT OPENING THE CLAVICLE UP. ADDITIONAL INFORMATION PROVIDED 10/8/2019: FLUORO WAS USED TO IDENTIFY THE LOCATION OF THE FRAGMENT, SO THERE IS NOT A RADIOLOGY REPORT AVAILABLE. THE TIP WAS SECURED BY THE BONE ITSELF. NO OTHER SECUREMENT WAS DONE TO THE OR MANAGER¿S KNOWLEDGE. THE DRILL THAT WAS INVOLVED IS RETAINED BY RISK MANAGEMENT AND WILL NOT BE RETURNED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9225755 ↗