Arthrex® AR-8943-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00888867052253), received between Dec 27, 2022 and Aug 14, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255864 ↗
• MalfunctionMar 10, 2026Break

  ON 17-FEB-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8943-15 LOW PRO DEPTH DEVICE FROM SET AR-8943S BROKE DURING A CASE WITH NO PIECES LEFT INSIDE THE PATIENT, WHO WAS UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557739 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT DURING THE ANKLE JOINT SURGERY, THE HOOK OF THE DEVICE BROKE OFF. THE BROKEN PIECE WAS 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 24518712 ↗
• MalfunctionFeb 25, 2026Incorrect Measurement

  ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-8943-15, DEPTH DEVICE, 2.7 / 3.5 / 4.0 MM, LOW PROFILE AND AN AR-2670, 2.7MM SCREW DEPTH INDICATOR, THESE 2 DEPTH GAUGES IN THE CLAVICLE FRACTURE TRAY WERE INACCURATE. THIS CAUSED INACCURACIES IN SCREW LENGTH MEASURED. THIS WAS DETECTED DURING A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY HAD TO USE X-RAY TO GUESS THE APPROPRIATE SCREW LENGTH. 4 SCREWS WERE WASTED DUE TO WRONG MEASUREMENT, AND THE SCREWS WERE TOO LONG. ON (B)(6) 2026 - THE 4 SCREWS USED WERE AR-8835-20 X 2, AR-8835-24 X 1 AND AR- 8835L-20 X 1. THEY REPLACED THE 4 SCREWS THAT WERE TOO LONG IN THE PRIMARY SURGERY. AS BOTH THE DEPTH DEVICES WERE UNABLE TO PROVIDE PROPER MEASUREMENT, THEY HAD TO REREVISE BY PUTTING SHORTER SCREWS AND PERFORMING AN X-RAY CHECK WHICH CAUSED THE SURGERY TO TAKE LONGER THAN IT WAS SUPPOSED TO. THE COMPLAINT INITIATOR THINKS IT TOOK LONGER THAN 15 MINUTES BECAUSE THE NURSE WENT OUT TO SEARCH FOR POSSIBLE PEEL DEPTH GAUGE AND CAME BACK WITH NO LUCK. THE SURGEON TRIED MANY TIMES TO GET THE CORRECT LENGTH AS WELL. THEY USED X-RAY MULTIPLE TIMES AT DIFFERENT ANGLES TO

  Patient problems: Insufficient Information

  MAUDE report 24441818 ↗
• MalfunctionFeb 20, 2026Break

  ON 04-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO DELAY OR PATIENT HARM. ADDITIONAL INFORMATION WAS PROVIDED BY THE REP ON 06-FEB-26 THAT THIS WAS DISCOVERED DURING AN ANKLE FRACTURE. THE INSTRUMENT WAS NOT USED WITH POWER AND A PIECE SNAPPED OFF BUT THE FRAGMENT WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401184 ↗
• MalfunctionFeb 2, 2026Break

  ON 12-JAN-2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE FROM AN RAR-9943S LOANER ANKLE FRACTURE SET SN: 14188044 HAD A BROKEN THREADED RING THAT KEEPS THE STICK IN PLACE. IT WAS REPORTED THAT THEY WERE UNSURE IF THE RING HAPPENED TO BE THE WRONG SIZE OR WAS ACTUALLY BROKEN. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24238668 ↗
• MalfunctionDec 24, 2025Break; Break

  ON 12/03/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE NECK OF THE DEVICE BROKE UPON ATTEMPT OF USE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887482 ↗
• MalfunctionDec 15, 2025Break; Break

  ON (B)(6) 2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8943-15 LOW PRO DEPTH DEVICE WAS BROKEN DURING A CASE. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23806602 ↗
• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 11/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE CAME APART. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644903 ↗
• MalfunctionNov 4, 2025Break; Break

  ON 10/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE NECK OF THE DEVICE BROKE OFF FROM THE BASE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464890 ↗
• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE JOINT SURGERY THE DEVICE BROKE AT THE WELD SEAM. 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.

  Patient problems: Insufficient Information

  MAUDE report 22484749 ↗
• MalfunctionMay 5, 2025Break; Break

  ON 04/21/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(6) THAT AN AR-8943-15 LOW PRO DEPTH DEVICE WAS BROKEN. THE PORTION OF THE DEPTH GAUGE THAT HOOKS INTO THE BONE WAS DISCONNECTED FROM THE MEASURING PORTION. IT APPEARS AS IF THE WELD CAME APART. THE ACCOUNT DISPOSED OF THE DEPTH GAUGE DOWN IN SPD FOLLOWING THE CASE, AS IT WAS BROKEN. THIS WAS NOTICED AT THE BEGINNING OF THE CASE, AND NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960527 ↗
• MalfunctionApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 04/01/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT AN AR-8943-15 DEPTH DEVICES SMALLER METAL PIECE THAT HOOKS ONTO THE CORTEX FOR MEASUREMENT PULLED OUT OF THE LARGER PIECE WITH THE DENOTED DEPTHS. THIS OCCURRED WHEN THE SURGEON ATTEMPTED TO USE THE DEPTH GAUGE FROM THE TI ANKLE FX SET, AND THE SMALLER METAL PIECE THAT HOOKS ONTO THE CORTEX FOR MEASUREMENT PULLED OUT OF THE LARGER PIECE WITH THE DENOTED DEPTHS.

  Patient problems: Insufficient Information

  MAUDE report 21883790 ↗
• MalfunctionFeb 6, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE HAD THE PROBE ON THE END OF THE DEPTH GAUGE FALL OUT OF WHERE IT GETS WELDED. IT SEEMED THAT THERE WAS VERY LITTLE WELDING AND NOT THE PROPER AMOUNT TO HOLD THE PROBE ON. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 01/23/2025: THE DEVICE BROKE WHILE THE SURGEON WAS ABOUT TO MEASURE THE DRILLED SOCKET. THE SURGEON COMPLETED THE CASE USING THE DEPTH GAUGE WITH THE SAME PART NUMBER FROM ANOTHER SET. THERE WAS NO CASE DELAY, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION WITH BACKUP FIXATION UTILIZING THE CORTICAL FIXATION SET ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326174 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A PATELLA FRACTURE SURGERY THE NARROW "STICK" HAS BROKEN OFF. THE BROKEN PIECE WAS RECEIVED OUT OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294941 ↗
• MalfunctionJan 23, 2025Break; Break

  ON 12/30/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE HAD THE 3.5 SLIDING DEPTH GAUGE FROM THE WRIST PLATING SET APPEARING TO BE BROKEN DURING A CASE. WHEN GRABBING FROM THE SET, THEY NOTICED IT WOULD NOT SLIDE CORRECTLY. AFTER TAKING IT APART, THEY SAW THAT THE WELDED PART, WHERE THE DEPTH WIRE MEETS THE MEASURING SECTION, WAS BROKEN INTO TWO PIECES. NO PIECES BROKE OFF INSIDE THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A DISTAL RADIUS REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217836 ↗
• MalfunctionJan 13, 2025Break; Break

  ON 12/17/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137937 ↗
• MalfunctionOct 30, 2024Defective Device; Defective Device

  ON 10/24/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(6) THAT AN AR-8943-15 DEPTH DEVICE HAS THE TIP UNSOLDERED. THIS OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20570245 ↗
• MalfunctionSep 12, 2024Break; Break

  ON 08/27/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06647738 THAT AN AR-8943-15 DEPTH DEVICE MEASURING TIP BROKE AFTER THE CASE. THIS WAS DISCOVERED AFTER THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207564 ↗
• MalfunctionJun 25, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06582746 THAT AN AR-8943-15 DEPTH DEVICE GAUGE WAS BROKEN DURING A PROCEDURE. IT WAS STATED THAT THERE WAS NO ABNORMAL ACTIVITY AND THAT THE DEVICE FAILED IN USE BY THE SURGEON. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/3/2024: THE DEVICE WAS BROKEN WHEN THE SURGEON WENT TO FIRST USE IT. THE INNER MEASURING TOOL FELL OUT. NOTHING BROKE INSIDE THE PATIENT, AND THERE WAS NO CASE DELAY. THIS WAS DISCOVERED DURING AN ANKLE ORIF (USING TI ANKLE FX). THE CASE WAS COMPLETED WITH ANOTHER DEPTH DEVICE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607012 ↗
• MalfunctionMar 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06502306 THAT AN AR-8943-15 DEPTH DEVICE PIN CAME APART FROM THE MEASUREMENT HANDLE. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE REPAIR PROCEDURE ON (B)(6) 2024. THE DEVICE DID NOT BREAK INSIDE THE PATIENT. THE CASE WAS COMPLETED BY REINSERTING THE DEPTH PIN INTO THE HANDLE AND REMEASURED.

  Patient problems: Insufficient Information

  MAUDE report 18923516 ↗
• MalfunctionMar 18, 2024Incorrect Measurement; Incorrect Measurement

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE, 2.7 / 3.5 / 4.0 MM, LOW PROFILE FROM THE TITANIUM ANKLE FRACTURE TRAY, AR-9943S, WAS NOT MEASURING CORRECTLY. EVERY SCREW WAS MEASURED IMPROPERLY BECAUSE OF THE DEPTH GAUGE. THE GAUGE IS SUPPOSED TO BE 20MM ACCORDING TO WHAT IT IS READING IN THE BACK. IT IS 2MM OFF. THIS CAUSED EVERY SCREW TO BE OFF. THIS WAS DISCOVERED DURING A DISTAL FIBULA FX WITH SYNDESMOSIS AND DELTOID REPAIR WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922720 ↗
• MalfunctionFeb 20, 2024Break; Break

  ON 2/1/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE SKINNY PART OF AN AR-8943-15 DEPTH DEVICE, THAT SLIDES DOWN TO MEASURE A SCREW BROKE. THIS WAS DISCOVERED DURING A PROCEDURE; THE PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738992 ↗
• MalfunctionJan 9, 2024Break; Break

  ON 12/13/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE BROKE ON THE MAIN BODY OF THE GAUGE. THIS OCCURRED AFTER USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477279 ↗
• MalfunctionDec 28, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA (B)(4). THAT AN AR-8943-15 DEPTH DEVICE STICK PORTION IS BROKEN. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18413437 ↗