Arthrex® AR-9925SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867569423), received between Aug 10, 2026 and Sep 11, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Positioning Failure

  On 28-Aug-2026, a sales representative reported via email that an AR-9925SS Syndesmosis TightRope PRO Implant experienced a button deployment issue during an ankle syndesmosis procedure on (b)(6) 2026. After the implant was passed through the bone and plate, the button reportedly did not flip off the inserter as intended. The device was removed. No harm to the patient was reported.Additional information was received on 31-Aug-2026:The button failed to flip after being passed through the bone and plate. The surgeon attempted to deploy the implant according to the surgical technique and palpated the medial side of the ankle in an effort to facilitate button deployment; however, the button did not flip.The button was observed to remain attached to the inserter and did not appear to release from the inserter despite activation of the black deployment button.The entire implant was inserted through the fibula and tibia before the issue was identified. The implant was subsequently removed by pulling it straight out through the pre-drilled hole. Resistance was encountered during removal, and the TightRope construct began to tension; however, all implant components were successfully removed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733338 ↗
• MalfunctionSep 8, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667499 ↗
• MalfunctionAug 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50499701 ↗
• MalfunctionAug 10, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50192445 ↗