Arthrex® AR-9925TRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867569447), received between Aug 6, 2026 and Sep 17, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Loose or Intermittent Connection

  On 02-SEP-2026, it was reported by a sales representative via phone that an AR-9925T tightrope button, after drilling femoral tunnel and pressing button to seat tightrope, entire button came loose but was still attached to driver and pulled back through tunnel. Tried reseating to no effect. New device opened and case completed with no patient effect.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804481 ↗
• MalfunctionSep 15, 2026Material Twisted/Bent

  On (b)(6)2026, a sales representative reported via(b)(4) that an AR-9925T Syndesmosis Tight Rope PRO Implant experienced a bent inserter during insertion, resulting in premature deployment of the button. The deployed Tight Rope was cut out and replaced with a new implant, which was inserted without issue. The event occurred during an ankle fracture procedure on (b)(6)2026. The surgery was delayed by approximately 2 minutes. No additional anesthesia was administered, and no patient harm was reported.Additional information was received on 08-Sep-2026:The inserter was observed to be bent after exiting the far cortex. The button was deployed after the inserter bent as it exited the far cortex. No excessive resistance was encountered during insertion; however, slight resistance was noted while attempting to advance the button through the far cortex. Visual damage was observed on the L-shaped portion of the inserter following removal. No portion of the affected implant remained in the patient. The procedure was completed using a replacement implant of the same part number. The drill bit included in the kit was used to prepare the bone socket for insertion. The patient's bone quality was

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770803 ↗
• MalfunctionSep 9, 2026Detachment of Device or Device Component

  On 21-Aug-2026, a sales representative reported via email that an AR-9925T Syndesmosis TightRope PRO Implant experienced a button detachment from the TightRope prior to implantation. The issue was identified before use during a procedure on (b)(6) 2026. No patient harm was reported. Additional information was received on 26-Aug-2026: The issue was identified while passing the button through the tibia. The button was reportedly discovered to be detached when attempting to set it on the medial side after a portion of the device had already entered the patient. The detached button was accounted for; however, it could not be reattached to the inserter. A replacement device of the same part number and lot number was used to complete the procedure. No surgical delay was reported. The procedure being performed was an ankle fracture with syndesmosis repair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690175 ↗
• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668664 ↗
• InjuryAug 27, 2026Device Dislodged or Dislocated

  Patient problems: Loss of fracture reduction

  MAUDE report 50472835 ↗
• MalfunctionAug 6, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160486 ↗
• MalfunctionAug 6, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160169 ↗