Arthrex® AR-1595TCRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867019904), received between May 21, 2024 and Mar 20, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Break

  ON 27-FEB-2026, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-1595TC DRILL PIN BROKE OFF DURING A PROCEDURE ON (B)(6) 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649053 ↗
• MalfunctionFeb 20, 2026Break

  ON 02-FEB -2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1595TC PIN BROKE WHEN IT WAS PRESSED AGAINST THE BONE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399978 ↗
• MalfunctionJan 22, 2026Break

  ON 07-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-1595TC DRL PIN, ACL T-ROPE CLOSED EYELET,4MM SPADE TIP PINS BROKE IN THE FEMUR. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION AND THE FRAGMENTS WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 24144750 ↗
• MalfunctionJan 22, 2026Break

  ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-1595TC DRL PIN, ACL T-ROPE CLOSED EYELET,4MM SPADE TIP PINS BROKE IN THE FEMUR. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION AND THE FRAGMENTS WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 24144311 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE TIPS OF BOTH PINS AR-1595TC (LOT: 15458338 AND 15461606) BROKE DURING USE. ALL FRAGMENTS WERE 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 23888417 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE TIPS OF BOTH PINS AR-1595TC (LOT: 15458338 AND 15461606) BROKE DURING USE. ALL FRAGMENTS WERE 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 23888340 ↗
• InjuryAug 19, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1595TC, DRILL PIN, ACL TIGHTROPE®, CLOSED EYELET, 4 MM, THE SPADE TIP BROKE OFF WHEN DRILLING THROUGH FEMORAL CONDYLE. THIS WAS DETECTED DURING USE IN AN ACL REVISION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE BROKEN TIP WAS RETRIEVED AND A 2.4 DRILL PIN WAS USED TO CORRECT IT. ON (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED THAT THE PURPOSE OF THE REVISION PROCEDURE WAS BECAUSE THE PATIENT'S INITIAL PATELLAR TENDON ACL RECONSTRUCTION HAD FAILED WHEN THE PATIENT RETURNED TO SPORT TOO EARLY WITHOUT COMPLETING AN ADEQUATE RETURN TO PLAY/ REHABILITATION PROGRAM. ON (B)(6) 2025 - THE COMPLAINT INITIATOR RECEIVED UPDATES THAT ALTHOUGH INITIALLY IT WAS BELIEVED THAT ALL OF THE BROKEN MATERIAL WAS REMOVED FROM THE PATIENT DURING THE SURGERY. SUBSEQUENTLY ON A PRECAUTIONARY X-RAY THERE WAS STILL METAL LEFT IN THE PATIENT. THIS PATIENT HAD A SUBSEQUENT FOLLOW UP SURGERY YESTERDAY FOR THE FOREIGN MATERIAL TO BE REMOVED WHICH WAS PART OF THE SPADETIP DRILL PIN. NO REPORTED ¿PATIENT HARM¿ APART FROM HAVING TO HAVE A FOLLOW-UP SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22842751 ↗
• MalfunctionApr 25, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT FOR AN AR-1595TC, DRILL PIN, ACL TIGHTROPE®, CLOSED EYELET, 4 MM, AFTER MICRO FRACTURING THE LATERAL CONDYLE, THE 4MM SPADE TIP WAS INSERTED INTO THE MICROFRACTURE HOLE BY HAND, THE POWER TOOL WAS ATTACHED AND ACTIVATED ON THE DRILL, THE HEAD OF THE SPADE TIP PIN BROKE OFF AND WAS IMBEDDED IN THE LATERAL FEMORAL CONDYLE. A CURETTE WAS USED TO REMOVE THE METAL FRAGMENT AND THEY PROCEEDED WITH THE OPERATION. THIS WAS DETECTED ON (B)(6) 2025 DURING USE IN AN ACLBTB + LET + LATERAL MENISCAL REPAIR PROCEDURE. THE PROCEDURE WAS COMPLETED AS ANOTHER 4MM SPADE TIP DRILL PIN WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 21910144 ↗
• MalfunctionApr 4, 2025Break; Break

  ON 17 MARCH 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1595TC DRL PIN, ACL T-ROPE CLOSED EYELET,4MM WAS REPORTED TO HAVE SNAPPED OFF AT THE TIP. THIS OCCURRED ON (B)(6) 2025 DURING USE IN AN UNKNOWN PROCEDURE. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 21771997 ↗
• MalfunctionFeb 26, 2025Dull, Blunt; Defective Device; Dull, Blunt; Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED ON 4/21/2025: DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, IT WAS IDENTIFIED THAT THE AR-1595TC DRILL PIN HAD AN INCONSISTENT DIAMETER ALONG ITS LENGTH. THIS ISSUE PREVENTED THE PROPER ADVANCEMENT OF THE CANNULATED REAMER OVER THE PIN. THE DRILL PIN WAS NOT STUCK, BUT ITS IRREGULAR DIMENSIONS INTERFERED WITH THE REAMING PROCESS. NO PIECES OF THE INSTRUMENT BROKE INSIDE THE PATIENT, AND NO CASE DELAY WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING A NEW 4MM DRILL PIN (AR-1595TC). THE PATIENT'S BONE QUALITY WAS ASSESSED AS GOOD, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468924 ↗
• MalfunctionFeb 24, 2025Break; Break

  ON 02/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1595TC DRILL PIN IS DAMAGED. THE TIP OF THE PIN BROKE OFF WHILE BEING DRILLED INTO A FEMUR AND BECAME STUCK. IT WAS RETRIEVED WITH A GRASPER AND NO METAL WAS LEFT IN THE PATIENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447897 ↗
• MalfunctionMay 21, 2024Break; Break

  ON 04/23/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-1595TC DRILL PINS SHADE TIP BROKE OFF. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2024 WHEN INSERTED INTO THE BONE, THE DEVICE BROKE IT TOOK A COUPLE OF MINUTES TO RETRIEVE THE FRAGMENT. THE CASE WAS COMPLETED USING ANOTHER PIN

  Patient problems: Insufficient Information

  MAUDE report 19357693 ↗