Arthrex® AR-1410LPRecalls & reported problems
Arthrex, Inc. · REAMER, LOW PROFILE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex AR-1410LP low profile reamer is a hand-operated orthopedic surgical instrument used to widen bone tunnels, most often during knee ligament reconstruction. Reports mostly describe the reamer tip or blade breaking off during surgery, sometimes leaving a fragment in the patient that had to be retrieved. There are 30 reports, 3 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00888867016811), received between Oct 19, 2020 and Sep 9, 2026 — classified as 3 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Break” (29 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
- Break29
- Defective Device1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Break
On 26-Aug-2026, it was reported by a sales Representative via (b)(4) that an AR-1410LP low profile reamer broke while drilling general ACL tunnel. No additional anesthesia needed. Broken piece was retrieved. New drill was opened to complete case with no patient effect.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694677 ↗MalfunctionSep 9, 2026Break
On 26-Aug-2026, it was reported by a sales Representative via (b)(4) that an AR-1410LP low profile reamer broke off while drilling femoral tunnel of ACL. Noticed during a case, device swapped, piece retrieved, and case completed with no patient effect.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694382 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE DEVICE BROKE WHEN REAMING THE TIBIA. ALL PARTS 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 24267097 ↗MalfunctionNov 17, 2025Break; Break
ON 10/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1410LP REAMER TIP BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23567696 ↗MalfunctionAug 5, 2025Break; Break
ON 07/16/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1410LP LOW PROFILE REAMER HEAD BROKE OFF. THIS OCCURRED DURING AN ACL PROCEDURE. THE FRAGMENT WAS RETRIEVED, AND THE CASE WAS COMPLETED USING A NEW REAMER.
Patient problems: Insufficient Information
MAUDE report 22713402 ↗MalfunctionJun 17, 2025Break; Break
ON 05/08/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1410LP LOW PROFILE REAMER BROKE. THIS OCCURRED DURING AN ACL RECONSTRUCTION WHERE ALL FRAGMENTS WERE RETRIEVED AND THE PROCEDURE WAS ABLE TO BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22233327 ↗MalfunctionApr 18, 2025Break; Break
ON 04/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4), AN AR-1410LP LOW PROFILE REAMER, 10 MM, HAD THE WING SHEARED OFF AND WAS RECOVERED WITHIN THE BODY. ALL PIECES WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING AN ACL REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21868491 ↗MalfunctionNov 8, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED ON 12/11/2024: ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO CASE DELAY REPORTED. A NEW PRODUCT WAS OPENED TO PERFORM THE SURGERY AND COMPLETED THE CASE SUCCESSFULLY. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED DUE TO THE INSTRUMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20639863 ↗MalfunctionNov 7, 2024Break; Break
ON 10/21/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4). THAT AN AR-1410LP LOW PROFILE REAMER BLADE OF THE LOW-PROFILE REAMER BROKE OFF OF THE SHAFT. THIS OCCURRED DURING A PROCEDURE AS THE SURGEON WAS DRILLING THE FEMORAL BONE TUNNEL.
Patient problems: Insufficient Information
MAUDE report 20630730 ↗MalfunctionJun 21, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06578399 THAT AN AR-1410LP LOW PROFILE REAMERS TIP BROKE OFF. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 19586608 ↗MalfunctionJun 10, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ACL, THE TIP BENT DURING THE REAMING. ANOTHER REAMER WAS USED TO COMPLETE THE ACL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19504515 ↗MalfunctionJun 7, 2024Break; Break
IT WAS REPORTED THAT THE LOW PROFILE REAMER, AR-1410LP WAS BROUGHT TO THE BONE OVER THE DRILL PIN ON THE LATERAL FEMORAL CONDYLE, THE SURGEON PULLED BACK ON THE REAMER, STARTING IT OFF BONE AND WHEN CONTACT WAS MADE WITH THE BONE, THE REAMER FAILED AND BROKE APART. NO ADVERSE EFFECT TO THE PATIENT REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19491650 ↗MalfunctionMay 16, 2024Break; Break
ON 11/8/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1410LP REAMER BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19331973 ↗MalfunctionFeb 6, 2024Break; Break
ON 01/17/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1410LP LOW PROFILE REAMER BROKE. THIS OCCURRED DURING A CASE WHEN TUNNELING THE LOW PROFILE DRILL BIT BROKE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 18652844 ↗MalfunctionDec 15, 2023Break; Break
ON 11/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1410LP REAMER TIP BROKE OFF; THE ISSUE WAS NOTICED WHEN STARTING DRILLING THAT SOMETHING WAS OFF. THE CASE WAS COMPLETED WITH A REPLACEMENT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 18340633 ↗MalfunctionOct 30, 2023Break; Break
ON 10/02/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06046491 THAT AN AR-1410LP REAMER HAD AN ISSUE. THE REAMER HEAD BROKE DURING A REVISION DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2023 DURING REAMING. THEY PULLED OUT THE BROKEN PIECE FROM THE PATIENT, AND THE BROKEN PIECE WAS FULLY RETRIEVED. THE REAMER WAS REPLACED, AND THE SURGERY CONTINUED. THERE WERE NO ISSUES WITH THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SECOND SURGERY WAS NECESSARY. THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR RETURN. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/13/2023, THE DISTRIBUTOR PROVIDED THE FOLLOWING INFORMATION VIA EMAIL AND PHONE: THE REVISION DISTAL BICEPS PROCEDURE WAS NECESSARY BECAUSE THE INITIAL DISTAL BICEPS REPAIR PROCEDURE HAD FAILED OVER TIME. IT COULD NOT BE CONFIRMED IF ARTHREX PRODUCTS HAD BEEN USED IN THE INITIAL PROCEDURE AND WERE EXPLANTED IN THE REVISION SURGERY. A CASE DELAY OF 2 MINUTES WAS REPORTED IN THE REVISION SURGERY, AND NO ADDITIONAL ANESTHESIA WAS NEEDED. THERE WERE NO PICTURES TAKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18031388 ↗MalfunctionSep 14, 2023Break; Break
ON 8/21/2023, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-1410LP LOW PROFILE REAMER END BROKE INTO THREE PIECES WHILE DRILLING THE PATIENT'S LEFT KNEE. ALL BROKEN FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 17745529 ↗MalfunctionAug 21, 2023
WHILE USING ARTHREX REAMER LOW PROFILE 10MM REF AR-1410LP LOT 14922102, INSIDE PATIENT'S LEFT KNEE, THE REAMER END BROKE INTO THREE PIECES, ALL THREE PIECES REMOVED FROM KNEE. CONTINUED AND COMPLETED WITH SURGERY WITHOUT ANY OTHER ADVERSE EVENTS. REAMER PIECES GIVEN TO NURSE MANAGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17583745 ↗InjuryAug 11, 2023Break; Break
ON 7/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-1410LP LOW PROFILE REAMER BROKE IN HALF. THE SURGEON WAS DRILLING THE FEMORAL TUNNEL WHEN THE FLAT REAMER TIP BROKE OFF FROM THE SHAFT INTO TWO PIECES. THE REAMER SHAFT WAS STILL ATTACHED TO THE DRILL VIA CHUCK AND WAS SAFELY REMOVED FROM THE PATIENT USING THE MEDIAL PORTAL. THE FIRST BROKEN FRAGMENT WAS RETRIEVED QUICKLY WITH A GRASPER FROM THE MEDIAL PORTAL. THE SECOND FRAGMENT WAS LOCATED IN THE POSTERIOR LATER COMPARTMENT OF THE KNEE. REMOVING THE FRAGMENT DELAYED THE CASE ABOUT TWENTY-FOUR MINUTES, AND THE SURGEON HAD TO CREATE AN ADDITIONAL LATERAL PORTAL TO ENSURE SAFE REMOVAL FROM THE PATIENT. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 7/14/2023: THE CASE WAS COMPLETED IN STANDARD FASHION WITH AN ACL TIGHTROPE AND INTERFERENCE SCREW.
Patient problems: Insufficient Information
MAUDE report 17512760 ↗MalfunctionJul 21, 2023Break; Break
ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1410LP LOW PROFILE REAMER BROKE. THIS OCCURRED DURING A PROCEDURE ON (B)(6)2023, THE HEAD OF THE DEVICE BROKE DURING THE PROCEDURE. THERE WAS A DELAY IN COMPLETING THE PROCEDURE HOWEVER NO ADDITIONAL ANESTHESIA NEEDED TO BE ADMINISTERED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17374716 ↗MalfunctionJul 6, 2023Break; Break
ON(B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1410LP LOW PROFILE REAMER TIP BROKE OFF IMMEDIATELY WHEN TRYING TO CREATE A TUNNEL. ALL THE BROKEN FRAGMENTS WERE RETRIEVED SUCCESSFULLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 6/8/2023: THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2023, AND THE REAMING PROCESS CONTINUED WITH A REUSABLE ACORN REAMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17267634 ↗MalfunctionJun 7, 2023Break; Break
ON 5/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1410LP LOW PROFILE REAMER BROKE INSIDE THE PATIENT WHILE REAMING THE FEMUR, BOTH BLADES ON THE REAMER BROKE. ALL THE BROKEN FRAGMENTS WERE RETRIEVED, AND ANOTHER AR-1410LP LOW PROFILE REAMER WAS USED TO COMPLETE THE REAMING PROCESS. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17080287 ↗MalfunctionJan 23, 2023Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1410LP LOW PROFILE REAMER BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. NO FURTHER INFORMATION WAS GIVEN AT THIS TIME.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 16223170 ↗MalfunctionJan 3, 2023Break
IT WAS REPORTED ON 12/13/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1410LP REAMER BROKE. CASE INVOLVEMENT, DEVICE BROKE DURING USE.
Patient problems: Insufficient Information
MAUDE report 16086593 ↗MalfunctionDec 1, 2022Break
IT WAS REPORTED THAT DURING A SURGERY THE DRILL WAS BEING USED FOR THE FIRST TIME, AND AT THE FIRST CONTACT WITH THE BONE, AFTER TWO SECONDS OF USAGE, IT GOT BROKEN INTO TWO PIECES. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15893332 ↗
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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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