Arthrex® AR-1005Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867002401), received between Feb 9, 2021 and Sep 15, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  It was reported that during the anterior cruciate ligament surgery, while placing a staple and striking the instrument with a hammer, one of the instrument¿s retaining tabs, which holds the staple in place, broke off. The broken piece was retrieved from the patient. Per complaint reporter there was no harm for patient, operator or third party. The surgery was finished successfully with a new device with the same part number. It was not necessary to switch the surgical technique or do a second surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774949 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT THE STAPLE DRIVER HAS A BROKEN TIP. IT WAS ASSUMED TO HAVE BEEN BROKEN DURING A SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321335 ↗
• MalfunctionJun 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STAPLE HANDLE SEEMS TO BE COLD WELDED TOGETHER. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480596 ↗
• MalfunctionJan 3, 2024Defective Device; Defective Device

  ON 12/05/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-1005 DRIVER WELD FAILED ON THE PART THAT HOLDS THE JAW. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437099 ↗
• InjuryFeb 9, 2021Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIP OF THE STAPLE DRIVER, AR-1005, BROKE. THE TIP OF THE DRIVER WAS RETRIEVED AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. NO FURTHER DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11302063 ↗