Arthrex® AR-1408LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867016729), received between Jan 26, 2021 and Mar 16, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Break

  ON 23-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-1408LP REAMER HAD THE TIP BREAK OFF INSIDE OF THE UNI CORTICAL SOCKET DURING A DISTAL BICEPS REPAIR. THE DISTAL BICEPS IMPLANTS HAD TO BE REMOVED, BROKEN TIP WAS THEN REMOVED. THE DISTAL BICEP WAS REPAIRED A FINAL TIME WITH NO COMPLICATIONS. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606090 ↗
• MalfunctionNov 3, 2025Break; Break

  ON 10/21/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-1408LP 8MM LOW-PROFILE REAMER BROKE DURING AN ACL RECONSTRUCTION + MENISCUS SUTURING. HOW THE INCIDENT WAS RESOLVED: THE DRILL PERFORATED THE CORTICES. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452456 ↗
• MalfunctionDec 31, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 01/03/2025: THE PATIENT HAD NO ADVERSE EFFECTS DUE TO THE ISSUE. NO REVISION SURGERY IS NEEDED TO REMOVE THE FRAGMENT. THERE WAS NO DELAY IN THE PROCEDURE, AND NO ADDITIONAL ANESTHESIA WAS NEEDED. NO MEDICAL INTERVENTIONS WERE REQUIRED FOR THE PATIENT, AND THERE WAS NO REPORTED REDUCTION IN THE PATIENT'S QUALITY OF LIFE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21048453 ↗
• MalfunctionSep 4, 2024Break; Break

  ON 8/5/2024, AN FDA MEDSUN NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-1408LP LOW PROFILE REAMER, 8 MM BROKE WHILE IN THE MEDULLARY CANAL OF THE PROXIMAL RADIUS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A RIGHT ELBOW DISTAL BICEPS REPAIR WITH AUGMENT. THE BICEPS DEMONSTRATED SOME INTERSTITIAL TEARING, THUS, THE SURGEON ELECTED TO PROCEED WITH A BIO BRACE AUGMENT. THIS WAS THEN SUTURED TO THE BICEPS TENDON UTILIZING 0 VICRYL SUTURES. FOLLOWING THIS, THE ARTHREX FIBERLOOP WAS THEN PLACED THROUGH THE TENDON AND THE AUGMENT. THIS WAS THEN PLACED THROUGH THE PEC BUTTON AND SIZED. THEN, THE PROXIMAL PORTION OF THE HOLE, WAS REAMED, IN WHICH THE BICEPS TENDON WAS DOCKED. UNFORTUNATELY, AT THIS POINT, ONE OF THE TONGS OF THE ARTHREX 8MM REAMER DRILL BIT BROKE WHILE IN THE MEDULLARY CANAL OF THE PROXIMAL RADIUS. THE SURGEON COULD NOT REMOVE IT, AND THE SURGEON PROCEEDED TO DUNK THE BICEPS TENDON AND VERIFY THE CORRECT POSITION. THIS WAS THEN DUNKED INTO THE HOLE AND SUTURED. THIS DEMONSTRATED A VERY NICE REPAIR WITH GOOD FIXATION. THE TOURNIQUET WAS THEN DEFLATED TO MAKE SURE THERE WERE NO BLEEDERS. THE WOUND WAS THEN COPIOUSLY IRRIGATED AND CLO

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20138795 ↗
• MalfunctionAug 6, 2024Break; Break

  ON 07/15/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-1408LP LOW PROFILE REAMERS TIP WAS BROKEN. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19919783 ↗
• MalfunctionAug 15, 2022Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS SURGERY ONE WING OF THE DEVICE BROKE OFF. IT WAS FURTHER REPORTED THAT ONE FRAGMENT REMAINED INSIDE THE BONE. 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: Foreign Body In Patient

  MAUDE report 15224023 ↗
• MalfunctionApr 18, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE TIP OF AN AR-1408LP REAMER BROKE INSIDE THE PATIENT, THE PATIENT WAS NOT AFFECTED OR HARMED. THE SURGEON WAS ABLE TO REMOVE THE PIECES FROM THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2022, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING A DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED AS STATED AND THE SURGEON WAS HAPPY WITH THE REPAIR. THE BONE QUALITY OF THE PATIENT WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135436 ↗
• MalfunctionFeb 7, 2022Break; Difficult to Remove

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1408LP REAMER BROKE WHILE DRILLING ON THE FAR CORTEX OF THE PATIENT BONE. THE REAMER IS LODGE INTO THE BONE AND NO FLOATING AROUND, THEREFORE, SURGEON DECIDED TO LEAVE IT INSIDE THE PATIENTS AS HE RECOMMENDED THAT REMOVING IT WOULD CAUSE MORE HARM. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A LEFT DISTAL BICEP REPAIR PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13471612 ↗
• MalfunctionAug 16, 2021Break

  DURING AN ACL PROCEDURE, THE HEAD OF THE LOW-PROFILE REAMER BROKE OFF WHEN DRILLING THE FEMORAL SOCKET. THIS WAS RETRIEVED IN ONE PIECE AND THE SURGEON WAS CONFIDENT AND SATISFIED THERE WAS NO ADDITIONAL FRAGMENTS REMAINING IN THE PATIENT. THE SURGERY CONTINUED AS NORMAL AND NO ADVERSE EVENT HAS BEEN REPORTED AS OF THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324981 ↗
• InjuryJan 26, 2021Break

  IT WAS REPORTED THAT DURING A (B)(6) 2021 DISTAL BICEPS REPAIR PROCEDURE AN AR-1408LP, LOW PROFILE REAMER (LOT 11156025) WAS BEING USED OVER A 2.4 GUIDE PIN. A UNICORTICAL TUNNEL WAS FORMED, THE BUTTON WAS PASSED AND THE TENODESIS SCREW WAS PLACED. THE INCISION WAS CLOSED AND AS THE BACK TABLE WAS BEING TORN DOWN IT WAS NOTICED THAT THE WINGS OF THE REAMER HAD BROKEN OFF. FLUORO WAS BROUGHT IN AND THE PIECES WERE FOUND TO BE IN THE PATIENT BONE. THE PIECES WERE RETAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11230844 ↗