Arthrex® AR-7255Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867121041), received between Dec 2, 2025 and Sep 21, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Split, Cut or Torn

  On (b)(6) 2026, it was reported by an Arthrex Subsidiary Employee via (b)(4) that an AR-7255 FiberWire #0 suture was cut with a Scorpion forceps. This was discovered during use with no patient harm reported. Additional information has been requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838046 ↗
• MalfunctionDec 3, 2025Break; Break

  ON 11/19/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(6) THAT A QTY. 4 OF (B)(4) FIBERWIRE #0 SUTURES BROKE WHEN BEING PASSED THROUGH THE MENISCUS BY AN (B)(4) KNEE SCORPION AS THE CLAMP DID NOT GRIP THE SUTURE AND BROKE IT IN THE CENTER. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707274 ↗
• MalfunctionDec 3, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 4 OF AR-7255 FIBERWIRE #0 SUTURES BROKE WHEN BEING PASSED THROUGH THE MENISCUS BY AN AR-12990 KNEE SCORPION AS THE CLAMP DID NOT GRIP THE SUTURE AND BROKE IT IN THE CENTER. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707263 ↗
• MalfunctionDec 2, 2025Break; Break

  ON 11/19/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 4 OF AR-7255 FIBERWIRE #0 SUTURES BROKE WHEN BEING PASSED THROUGH THE MENISCUS BY AN AR-12990 KNEE SCORPION AS THE CLAMP DID NOT GRIP THE SUTURE AND BROKE IT IN THE CENTER. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695379 ↗
• MalfunctionDec 2, 2025Break; Break

  ON 11/19/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 4 OF AR-7255 FIBERWIRE #0 SUTURES BROKE WHEN BEING PASSED THROUGH THE MENISCUS BY AN AR-12990 KNEE SCORPION AS THE CLAMP DID NOT GRIP THE SUTURE AND BROKE IT IN THE CENTER. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695264 ↗