Arthrex® AR-7000-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00888867040908), received between Oct 5, 2023 and May 8, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT DURING A LATARJET SURGERY, WHILE DRILLING 4.5MM SCREWS, THE DRILL GOT STUCK IN THE BONE AND BROKE. A PART ABOUT 1 CM LONG REMAINED IN THE PATIENT'S 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 25124453 ↗
• MalfunctionFeb 27, 2026Dull, Blunt

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE AR-7000-14 WAS BROKEN/DULL DRILL BIT AND THE SURGERY WAS NOT A SUCCESS. NO FURTHER INFORMATION WAS PROVIDED. UPDATE 16-FEB-2026: IT WAS CONFIRMED THAT THE DEVICE WAS DULL AND NOT BROKEN. THE ERROR OCCURRED DURING A MINI OPEN LATARJET SURGERY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DRILL AND SOME OTHER SCREWS THAT HAD ANOTHER PURPOSE AND WERE NOT SUITED FOR THIS PROCEDURE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474497 ↗
• MalfunctionFeb 2, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE LATARJET SURGERY, THE CANNULATED DRILL PREVENTED THE K-WIRE FROM BEING INSERTED THROUGH IT. 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 24237209 ↗
• MalfunctionJan 29, 2026Break

  ON 10-JAN-2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT (QTY. 2) OF AN AR-7000-14 DRILL BIT BROKE. IT WAS REMOVED AND THE SURGEON USED A NEW DRILL BIT, BUT IT BROKE AGAIN AND WAS REMOVED. THE FRAGMENTS REMAINED INSIDE THE PATIENT. THIS WAS DISCOVERED DURING THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24208160 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT DURING A LATARJET SURGERY THE 2.75 MM DRILL BIT ON THE LATARJET LOAN SET END BROKE OFF IN THE GLENOID AFTER DRILLING HOLES. THE BREAKAGE WAS UNNOTICED UNTIL AN X-RAY WAS TAKEN AT THE END OF THE PROCEDURE WHICH SHOWED THE FRAGMENTS AROUND THE SCREWS. AFTER THE X-RAY THE HOSPITAL STAFF INSPECTED THE DRILLS USED AND FOUND THAT ONE OF THE ENDS 2.75 MM DRILL BIT HAD SNAPPED. NOTHING THE SURGEON COULD DO AS THE SCREWS HAD BEEN INSERTED. NO FRAGMENTS WERE IN THE JOINT. APPROXIMATELY 2 MM OF METAL IN THE GLENOID BONE. SURGEON FINISHED THE SURGERY SAFELY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 24131605 ↗
• MalfunctionDec 16, 2025Break; Break

  ON 26TH NOVEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-7000-14, DRILL, 2.75 MM, 0.066'' CANNULATION, WAS BEING USED TO DRILL INTO THE GLENOID, THE DRILL HIT A STEINMAN PIN WHICH HAD PREVIOUSLY BEEN PLACED BY THE SURGEON, CAUSING THE 2.75MM CANNULATED DRILL TO BREAK INTO A NUMBER OF PIECES. SEVERAL PIECES WERE RETRIEVED BUT SOME WERE STUCK LODGED IN THE BONE TUNNEL. X-RAY WAS USED TO CONFIRM THAT ALL FRAGMENTS WERE INSIDE THE BONE TUNNEL AND STABLE (NOT LOOSE). THIS WAS DETECTED DURING A LATARJET PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SCREW WAS INSERTED INTO THE ALREADY DRILLED BONE TUNNEL WHERE THE REMAINING STABLE FRAGMENTS WERE LOCATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23818285 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LATARJET SURGERY, THE SCREWS WERE DIFFICULT TO INSERT BECAUSE THE DRILL WAS NOT DRILLING THE HOLES PROPERLY. THE FOLLOWING DAY, AN X-RAY OF THE PATIENT REVEALED THAT A PIECE OF THE DRILL HAD BROKEN OFF AND WAS STILL LODGED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 03-DEC-2025 MAJUNG - FURTHER INFORMATION RECEIVED FROM ARTHREX ES: THE PATIENT IS EXPERIENCING NO DISCOMFORT. THE FRAGMENTS VISIBLE AROUND THE SCREW IN THE X-RAYS WERE CAUSED BY THE DRILL.

  Patient problems: Foreign Body In Patient

  MAUDE report 23771180 ↗
• MalfunctionOct 27, 2025Break; Material Fragmentation; Break; Material Fragmentation

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-7000-14, DRILL, 2.75 MM, 0.066'' CANNULATION, THE LONG 2.75 MM CANNULATED DRILL TIP SHATTERED IN FRAGMENTS INSIDE PATIENT AFTER INSERTING GUIDE WIRES. THIS WAS DETECTED DURING USE IN A CONGRUENT-ARC LATARJET PROCEDURE USING THE GLENOID BONE LOSS SET WITH 3.75 MM CANNULATED SCREWS ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS X-RAYS WERE CALLED IN TO IDENTIFY AND REMOVE FRAGMENTS OF DEVICE INSIDE THE PATIENT, AND AN ALTERNATIVE 2.75MM CANNULATED SCREW USED IN PLACE. 2 FRAGMENTS UNABLE TO BE RETRIEVED IN PATIENT, BUT SURGEONS' CLINICAL JUDGEMENT WAS TO LEAVE AS IT IS INSIDE THE BONE AND WON'T CAUSE ANY ISSUES WITH THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23392781 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT AFTER DRILLING THE GLENOID DURING A LATARJET SURGERY, IT WAS DISCOVERED THAT THE DRILL BROKE. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE CMACKENBACH 2-SEP FURTHER INFORMATION WAS PROVDED THAT BITS OF THE DRILL ARE LEFT IN THE PATIENT. A PICTURE OF AN X-RAY OF THE PATIENT WAS PROVIDED (SEE ATTACHMENTS IN CASE). NO FURTHER SURGERIES ARE SCHEDULED TO REMOVE THE BROKEN PARTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23066366 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A LATERJET SURGERY THE DRILL BROKE OFF AT THE ATTACHMENT. 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 23043911 ↗
• MalfunctionJul 14, 2025Break; Break

  ON 06/18/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-7000-14 ILL BROKE DURING ASBB SURGERY AND THE BROKEN FRAGMENTS REMAINED IN THE PATIENT. AS MUCH AS POSSIBLE WAS REMOVED. THE SURGERY WAS COMPLETED BY USING A PRODUCT FROM ANOTHER MANUFACTURER. THE BONE QUALITY OF THE PATIENT WAS HARD

  Patient problems: Foreign Body In Patient

  MAUDE report 22500739 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT THE 2.75 MM DRILL WAS WORN OUT AND BROKEN. IN THE DISCARDED LEFTOVERS FROM THE SURGERY THE BROKEN PIECES WERE FOUND. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THIS WAS NOTICED DURING INCOMING INSPECTION. THERE WAS NO CASE INVOLVEMENT. NO FURTHER INFORMATION RECEIVED. UPDATE (B)(6) 06-JUN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED DEVICE BROKE DURING THE SURGERY. THE BROKEN PART WAS REMOVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH 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 22469286 ↗
• MalfunctionJul 8, 2025Break; Material Fragmentation; Break; Material Fragmentation

  ON 06/11/2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS-(B)(4) THAT AN AR-7000-14 DRILL BROKE AND FRAGMENTS REMAINED IN THE PATIENT. THIS WAS DISCOVERED DURING THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22440242 ↗
• MalfunctionMay 30, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A LATARJET SURGERY WITH CORACOID BONEBLOCK THE DRILLS WERE BLUNT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE, KHE, 30-MAY2025 THE DEVICE WAS PART OF THE LOAN SET DLS-GBL-IN-10145474.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118913 ↗
• MalfunctionMay 30, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A LATARJET SURGERY WITH CORACOID BONEBLOCK THE DRILLS WERE BLUNT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE, (B)(6), 30-MAY2025 THE DEVICE WAS PART OF THE LOAN SET DLS-GBL-IN-10145474.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118620 ↗
• MalfunctionMay 30, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A LATARJET SURGERY WITH CORACOID BONEBLOCK THE DRILLS WERE BLUNT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE, (B)(4), 30-MAY2025 THE DEVICE WAS PART OF THE LOAN SET (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118585 ↗
• MalfunctionMay 30, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A LATARJET SURGERY WITH CORACOID BONEBLOCK THE DRILLS WERE BLUNT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE, KHE, 30-MAY2025. THE DEVICE WAS PART OF THE LOAN SET DLS-GBL-IN-10145513.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118384 ↗
• MalfunctionMay 8, 2025Break; Break

  ON 04/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7000-14 DRILL BROKE APART IN THE GLENOID. THIS WAS DISCOVERED DURING THE CASE AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21984440 ↗
• MalfunctionApr 17, 2025Break; Break

  ON 03/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-7000-14 DRILL BIT BROKE AND SHATTERED INTO PIECES. THE PIECES WERE UNABLE TO BE REMOVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21855571 ↗
• MalfunctionJun 24, 2024Break; Break

  ON 05/30/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-7000-14 DRILL HAD A VERY SMALL PIECE OF THE DRILL BIT CHIPPED OFF. THIS OCCURRED DURING A SHOULDER SURGERY WHEN A VERY SMALL PIECE OF THE DRILL BIT CHIPPED OFF AND GOT STUCK IN THE RIGHT SURGICAL SHOULDER. THE ATTENDING ORTHOPEDIC SURGEON STATED THAT IT WOULD REMAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19593675 ↗
• MalfunctionJan 25, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A LATARJET PROCEDURE DURING DRILLING OF THE CORACOID BONE, OUTSIDE OF THE PATIENT, TWO DRILLS JUST FELL APART. WITH A THIRD NEW DRILL THE PROCEDURE COULD BE FINISHED, WITH NO DELAY FOR THE PATIENT. 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. UPDATE SWIT 10-JAN-2024: DRILLING OF THE CORACOID BONE IS OUTSIDE OF THE PATIENT, WHERE THE BONE IS HOLD FIRM IN A CLAMP. WITH THE FIRST DRILL THE TIP THAT FELL APART AND THE SECOND DRILL THAT WAS USED, A CRACK WAS SEEN. THE THIRD ONE THAT WAS USED WAS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581199 ↗
• MalfunctionJan 25, 2024Break; Break

  IT WAS REPORTED THAT DURING A LATARJET PROCEDURE DURING DRILLING OF THE CORACOID BONE, OUTSIDE OF THE PATIENT, TWO DRILLS JUST FELL APART. WITH A THIRD NEW DRILL THE PROCEDURE COULD BE FINISHED, WITH NO DELAY FOR THE PATIENT. 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. UPDATE SWIT 10-JAN-2024: DRILLING OF THE CORACOID BONE IS OUTSIDE OF THE PATIENT, WHERE THE BONE IS HOLD FIRM IN A CLAMP. WITH THE FIRST DRILL THE TIP THAT FELL APART AND THE SECOND DRILL THAT WAS USED, A CRACK WAS SEEN. THE THIRD ONE THAT WAS USED WAS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581164 ↗
• MalfunctionNov 9, 2023Break; Break

  ON 10/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-7000-14 2.75 MM DRILL BROKE OFF INSIDE THE PATIENT RIGHT AFTER THE FIRST AR-7000-26FT CANNULATED SCREW, FULLY THREADED WAS PLACED. A C-ARM WAS BROUGHT IN TO LOCATE THE BROKEN FRAGMENT. ONCE THE FRAGMENT WAS FOUND, THE SURGEON WAS UNABLE TO RETRIEVE IT. THE SURGEON RETAINED THE BROKEN FRAGMENTS USING ANOTHER AR-7000-26FT CANNULATED SCREW, FULLY THREADED, WHICH WAS MANUALLY IMPLANTED SINCE THERE WAS NO OTHER DRILL AVAILABLE TO IMPLANT THE REST OF THE SCREW. THIS WAS DISCOVERED DURING A DISTAL TIBIAL ALLOGRAFT PLACEMENT ON THE SHOULDER ON (B)(6) 2023. THE CASE WAS DELAYED FOR ABOUT THIRTY MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 18100330 ↗
• MalfunctionNov 1, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-7000-14 2.75 MM DRILL BROKE. WHILE DRILLING INTO THE GLENOID USING A 2.75MM DRILL BIT, DRILLING OVER A 1.6 K WIRE AND THE TIP OF THE 2.75MM DRILL BIT EXPLODED INTO SIX FRAGMENTS. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049267 ↗
• MalfunctionOct 5, 2023Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A SURGERY THE SURGEON TRIED TO USE ONE OF THE CANNULATED DRILLS, BUT IT WAS TOO INERT AND COULD NOT GET THROUGH THE BONE. THE SECOND ONE WAS ALSO IN A BAD SHAPE AND NOT WHAT THE CUSTOMER EXPECTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876518 ↗