Arthrex® AR-1595TRecalls & reported problems
Arthrex, Inc. · DRL PIN,ACL T-ROPE OPEN EYELET,4MM · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867019898), received between May 7, 2024 and Mar 25, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (7 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.
Reports received per month
Most reported problems
Device problems
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
- Foreign Body In Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Break
ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-1595T T-ROPE DRILL TIP SNAPPED WHILE DRILLING INTO FEMUR. NOTICED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688924 ↗MalfunctionFeb 27, 2026Break
IT WAS REPORTED THAT DURING A CRUICATE LIGAMENT REPAIR SURGERY THE TIP OF THE DEVICE BROKE OFF. THE BROKEN PART 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 24472379 ↗MalfunctionDec 22, 2025Break; Break
ON 12/01/2025, A DISTRIBUTOR REPORTED VIA (B)(4) THAT AN AR-1595T ACL TIGHTROPE OPEN EYELET SPADE TIP BROKE DURING MALLETING INTO THE FEMUR DURING AN ACL PROCEDURE. THIS WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863253 ↗MalfunctionDec 8, 2025Break; Break
ON 11/17/2025, A DISTRIBUTOR REPORTED VIA (B)(4) THAT (QTY. 3) AR-1595T ACL TIGHTROPE DRILL PINS BROKE OFF INSIDE THE PATIENT DURING AN ACL RECONSTRUCTION. ONE REMAINED IN THE PATIENT'S BONE, AND ONE WAS RETRIEVED FROM THE JOINT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Foreign Body In Patient
MAUDE report 23743589 ↗MalfunctionDec 8, 2025Break; Break
ON 11/17/2025, A DISTRIBUTOR REPORTED VIA (B)(4) THAT (QTY. 3) AR-1595T ACL TIGHTROPE DRILL PINS BROKE OFF INSIDE THE PATIENT DURING AN ACL RECONSTRUCTION. ONE REMAINED IN THE PATIENT'S BONE, AND ONE WAS RETRIEVED FROM THE JOINT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 23743257 ↗MalfunctionDec 8, 2025Break; Break
ON 11/17/2025, A DISTRIBUTOR REPORTED VIA (B)(4) THAT (QTY. 3) AR-1595T ACL TIGHTROPE DRILL PINS BROKE OFF INSIDE THE PATIENT DURING AN ACL RECONSTRUCTION. ONE REMAINED IN THE PATIENT'S BONE, AND ONE WAS RETRIEVED FROM THE JOINT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 23743149 ↗MalfunctionMay 7, 2024Break; Break
IT WAS REPORTED THAT DURING A KNEE SURGERY THE PIN BROKE OFF IN THE PATIENT'S KNEE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19260854 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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