Arthrex® AR-1510FS-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867196766), received between Sep 15, 2016 and Feb 24, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE DEVICES AR-1999 (LOT: 8002346), AR-1510FS-7 (LOT: 051702) AND AR-1996CD-1 (LOT: 47322249) DID NOT WORK PROPERLY. IT WAS IMPOSSIBLE TO SCREW THE SCREW IN WITH THE SCREWDRIVER, AND THE TIP OF THE AR-1510FS-7 DID NOT GRIP THE BONE. A PICTURE OF THE DEVICE AR-1510FS-7 SHOWED THAT THE FRONT PART OF THE DEVICE IS DAMAGED/ BROKEN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (T-HANDLE WRENCH). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430829 ↗
• InjuryFeb 23, 2026Material Twisted/Bent

  ON (B)(6) 2026, IT WAS REPORTED VIA EMAIL THAT AN AR-1510FS-7, STEPPED RATCHET DRILL SLEEVE WAS REPORTED TO BE UNUSABLE IN A CASE. THIS OCCURRED ON (B)(6) 2024 DURING A LEFT KNEE MENISCAL ROOT REPAIR. IT WAS REPORTED THAT AFTER DRILLING WITH THE K-WIRE TO HAVE THE REVERSE REAMER WORKING, THE SURGEON WAS INFORMED BY THE REPRESENTATIVE THAT THE REVERSE REAMER WAS NOT WORKING. AS SUCH THE SURGEON COULD NOT PROCEED TO PUT THE SUTURE INTO THE POSTERIOR ROOT OF THE MENISCUS AND PUT IT THROUGH INTO THE DRILLED PART OF THE BONE. THIS APPEARS TO HAVE BEEN DUE TO THE DRILL SLEEVE BEING BENT AND NOT ALLOWING THE FLIPCUTTER THROUGH. THE CASE WAS NOT COMPLETED SUCCESSFULLY AS NO ALTERNATIVE DRILL SLEEVE OR FLIPCUTTER WAS AVAILABLE TO BE USED. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413880 ↗
• MalfunctionJun 9, 2024Break; Break

  ON 3/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1204FF FLIPCUTTER III WOULD NOT CLOSE BACK TO 3.5 MM AFTER DRILLING THE BONE SOCKET. IT WAS NOTIFIED THAT THE FLIPCUTTER III WAS SLIGHTLY BENT, AND DURING RETRIEVAL, IT CRACKED THE TIP OF AN AR-1510FS-7 RATCHETING DRILL SLEEVE. CASE WAS COMPLETED BY OPENING A NEW AR-1204FF FLIPCUTTER III AND AR-1510FS-7 RATCHETING DRILL SLEEVE. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 3/7/2023: THE DRILL SLEEVE CRACKED AND DID NOT PRODUCE ANY LOOSE FRAGMENTS IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495248 ↗
• MalfunctionMay 14, 2024Break; Break

  ON 04/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1510FS-7 RATCHET DRILL SLEEVES TOP POPPED OFF, MAKING THE GUIDE UNUSABLE. THIS OCCURRED ON (B)(6) 2022 DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309393 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A MENISCAL ROOT REPAIR THE DRILL SLEEVE HEAD BECAME LOOSE AND CAME APART. NOTHING DROPPED INTO THE PATIENT. THE DOCTOR WAS STILL ABLE TO MANIPULATE IT INTO POSITION WITHOUT THE HEAD. IT MADE IT THROUGH THE CASE AND IT WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19265794 ↗
• MalfunctionApr 30, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 11/11/2021 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN AR-1510FS-7 RATCHET DRILL SLEEVE WAS DAMAGED. THIS WAS DISCOVERED DURING USE IN AN ACL PROCEDURE ON (B)(6) 2021. THE SURGEON INSERTED THE AR-1204FF FLIPCUTTER III THOUGH THE DRILL SLEEVE WHEN IT JAMMED. THE SURGEON POUNDED THE DEVICE TO GET THEM SEPARATED BREAKING A PIECE OF THE AR-120FF. ALL FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING A NEW AR-1204FF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213894 ↗
• MalfunctionApr 19, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 03/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1510FS-7 RATCHETING DRILL SLEEVE FOR FLIPCUTTERS TIP WAS BENT. THIS OCCURRED DURING AN ACL CASE, MAKING THE DRILL HOLE BIGGER. THE CASE CONTINUED USING A DIFFERENT SLEEVE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142723 ↗
• MalfunctionDec 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 11/22/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1510FS-7 RATCHETING DRILL SLEEVE FOR FLIPCUTTERS ROUND TOP PART WAS SEPARATED FROM THE SLEEVE. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18368618 ↗
• MalfunctionDec 12, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT A AR-1510FS-7 RATCHETING DRILL SLEEVE FOR FLIPCUTTER IS BROKEN. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959660 ↗
• MalfunctionDec 12, 2022Break; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A REVISION ANTERIOR CRUCIATE LIGAMENT SURGERY THE WHEEL MECHANISM OF THE FLIPCUTTER AR-1204FF (LOT 22F21) FAILED TO CLOSE THE DEVICE TO THE NEUTRAL POSITION RESULTING IN THE FLIPCUTTER FAILING TO CLOSE. THE SURGEON USED A SPINAL NEEDLE TO CLEAR THE DEBRIS TO GET THE FLIPCUTTER INTO THE NEUTRAL POSITION TO REMOVE IT FROM THE JOINT. DURING THIS PROCESS DAMAGE WAS DONE TO THE DRILL GUIDE AR-1510FS-7. PICTURES PROVIDED BY THE CUSTOMER OF THE AR-1510FS-7 SHOW THAT A PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958929 ↗
• MalfunctionAug 1, 2022Break

  ON 7/15/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1510FS-7 RATCHETING DRILL SLEEVE FOR FLIPCUTTER BROKE WHEN SURGEON WAS PLACING IT BY HAND. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137906 ↗
• MalfunctionJun 6, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE TOP PORTION OF AR-1510FS-7 DRILL SLEEVES BROKE OFF. THIS WAS DISCOVERED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604345 ↗
• MalfunctionJun 6, 2022Break

  ON 05/18/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE TOP PORTION OF (2) AR-1510FS-7 DRILL SLEEVES BROKE OFF. THIS WAS DISCOVERED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604069 ↗
• MalfunctionNov 22, 2021Break; Display or Visual Feedback Problem; Material Twisted/Bent

  ON 11/4/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8330H SHAVER HANDPIECE DISPLAYED AN H15 ERROR AND AN AR-1510FS-7 FLIPCUTTER RATCHET DRILL SLEEVE WAS BROKEN. THE HANDPIECE ISSUE WAS DISCOVERED DURING USE AND THE GUIDE ISSUE WAS DISCOVERED AFTER USE, BOTH FROM AN ACL RECONSTRUCTION PERFORMED ON (B)(6) 2021. THE HANDPIECE WAS REPLACED AT THE START OF THE CASE. THE GUIDE WAS FOUND TO BE BROKEN AFTER THE CASE, WITH CLEAN BENDS AT THE TIP WITH NO REPORTED JAGGED EDGES OF FRAGMENTS MISSING (SEE INTAKE PICTURES). THE CASE WAS COMPLETED WITH NO REPORTED PATIENT EFFECT.

  Patient problems: Insufficient Information

  MAUDE report 12853778 ↗
• InjuryJan 2, 2019Device Slipped

  IT WAS REPORTED THAT DURING THE SURGERY THE CAP CAME LOOSE FROM THE SHAFT. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE. UPDATE (B)(6) 2018: A MENISCAL ROOT SURGERY WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGERY WAS NOT COMPLETED SUCCESSFULLY BECAUSE DURING THIS SURGERY THE SLEEVE DID NOT STAY IN PLACE. IT SLID OFF THE MARK EVERY TIME THEY TRIED TO DRILL. THERE WAS NO SECOND DEVICE AVAILABLE DURING THE SURGERY. BECAUSE OF THIS INCIDENT, A SECOND SURGERY WILL BE NECESSARY. THEY DO NOT HAVE A DATE FOR THE SECOND SURGERY AS YET.

  Patient problems: No Code Available

  MAUDE report 8209086 ↗
• InjurySep 15, 2016Thermal Decomposition of Device; Component Missing

  IT WAS REPORTED THAT A STEPPED RATCHET DRILL SLEEVE, AR-1510FS-7, LOT 051520 ((B)(4)), WAS BEING USED IN AN ACL SOFT TISSUE AUTOGRAFT PROCEDURE. AFTER THE PROCEDURE, THE DEVICE WAS STERILIZED AND RETURNED TO THE DISTRIBUTOR'S OFFICE. UPON RETURN TO THE DISTRIBUTOR, IT WAS NOTED THAT THE TIP OF THE DRILL SLEEVE HAD A CHIP MISSING FROM IT. DURING THE PROCEDURE A FLIP CUTTER AR-1204AS-75, LOT 530659980 ((B)(4)) WAS BEING USED AND SPINNING AT FULL FORCE WHEN DRILLING THE FEMORAL TUNNEL. SALES REP STATES THE CHIP APPEARS ALMOST TO HAVE BEEN BURNED OUT, POSSIBLY BY THE FLIP CUTTER. IT IS UNKNOWN IF THE BROKEN PIECE MAY HAVE REMAINED IN THE PATIENT SINCE THE CHIP WAS NOT NOTICED UNTIL AFTER THE PROCEDURE, AFTER STERILIZATION AND AFTER RETURN TO THE DISTRIBUTOR OFFICE. THE CASE WAS COMPLETED SUCCESSFULLY WITH A COMPOSITE SCREW ON THE TIBIA. NO PATIENT INJURY REPORTED. FLIP CUTTER WILL NOT BE RETURNED AS IT WAS DISCARDED AFTER SURGERY. UPDATE (B)(6) 2016: SALES REP CONFIRMED WITH SURGEON THAT PATIENT HAS HAD NO ISSUES TO DATE AND NO FOLLOW UP X-RAYS HAVE BEEN TAKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5953209 ↗