Arthrex® AR-400PDRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888867102163), received between May 30, 2023 and Aug 12, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221006 ↗
• MalfunctionJul 29, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068815 ↗
• MalfunctionDec 23, 2025Material Fragmentation; Physical Resistance/Sticking; Material Fragmentation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE AR-400 HANDPIECE GOT VERY HOT, AND THE K-WIRE DIDN'T APPEAR TO ROTATE NORMALLY AND CREATED A SORT-OF METAL "DUST" AND EVEN SMALL METAL "FLAKES". IT CLEARLY JAMMED OR OBSTRUCTED THE K-WIRE FROM NORMAL ROTATION. AFTER NORMAL TROUBLESHOOTING, THE SURGEON SWITCH TO ANOTHER AR-400PD, AND EVERYTHING RAN SMOOTHLY. 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 23879531 ↗
• MalfunctionDec 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SURGERY THE K-WIRE COULD NOT BE GRASPED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830119 ↗
• MalfunctionNov 25, 2025Material Fragmentation; Noise, Audible; Material Fragmentation; Noise, Audible

  IT WAS REPORTED THAT AFTER INSERTING THE K-WIRE AND USING THE ATTACHMENT, A RATTLING SOUND CAN BE HEARD AND THERE IS ABRASION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 14-NOV-2025 IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A NAVICULAR BONE SCREW FIXATION SURGERY ON THE (B)(6). 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 23644379 ↗
• MalfunctionOct 15, 2025Positioning Failure; Positioning Failure

  ON 10/7/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-400PD PIN DRIVER IS NOT HOLDING PIN IN PLACE. NOTICED DURING A CASE, SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302027 ↗
• MalfunctionOct 15, 2025Positioning Failure; Positioning Failure

  ON 10/7/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-400PD PIN DRIVER IS NOT HOLDING PIN IN PLACE. NOTICED DURING A CASE, SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301683 ↗
• MalfunctionJul 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SURGERY WHEN THE DEVICE IS BLOODY, THE JAWS ON THE PINDRIVER STICK TOGETHER AND CAN NO LONGER BE OPENED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494114 ↗
• MalfunctionMay 6, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ACL REPAIR SURGERY THE HOLDING MECHANISM OF THE DEVICE NO LONGER WORKED WHEN LIQUID OR BLOOD GETS INTO THE DEVICE. 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 21969244 ↗
• MalfunctionMay 6, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ACL REPAIR SURGERY THE HOLDING MECHANISM OF THE DEVICE NO LONGER WORKED WHEN LIQUID OR BLOOD GETS INTO THE DEVICE. 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 21969243 ↗
• MalfunctionMay 6, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ACL REPAIR SURGERY THE HOLDING MECHANISM OF THE DEVICE NO LONGER WORKED WHEN LIQUID OR BLOOD GETS INTO THE DEVICE. 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 21969240 ↗
• MalfunctionMay 6, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ACL REPAIR SURGERY THE HOLDING MECHANISM OF THE DEVICE NO LONGER WORKED WHEN LIQUID OR BLOOD GETS INTO THE DEVICE. 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 21969102 ↗
• MalfunctionApr 22, 2025Connection Problem; Connection Problem

  ON 04/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-400PD DRILLSAW SPORTS 400 SYSTEM WOULD NOT HOLD THE PIN. THEY TRIED A FEW TIMES TO GET IT TO HOLD AND THEN SWITCHED TO A DIFFERENT ONE THAT WORKED TO COMPLETE THE CASE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884053 ↗
• MalfunctionFeb 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ACL REPAIR SURGERY THE JAW IS STUCK AND CANNOT BE OPENED OR CLOSED ANYMORE WHEN LIQUID OR BLOOD IS ENTERING. IT IS GETTING STICKY. THE WIRE CANNOT BE CLAMPED ANYMORE AND THE DRILL WIRE BECOMES HOT AND IS TORNING OFF. 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 21447764 ↗
• MalfunctionFeb 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ACL REPAIR SURGERY THE JAW IS STUCK AND CANNOT BE OPENED OR CLOSED ANYMORE WHEN LIQUID OR BLOOD IS ENTERING. IT IS GETTING STICKY. THE WIRE CANNOT BE CLAMPED ANYMORE AND THE DRILL WIRE BECOMES HOT AND IS TORNING OFF. 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 21447753 ↗
• MalfunctionSep 10, 2024Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06641969 THAT AN AR-400PD PIN DRIVER ATTACHMENT WOULD NOT GRASP THE PINS. THIS OCCURRED DURING A CASE, THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184925 ↗
• MalfunctionSep 10, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ELLBOW FRACTURE SURGERY THE TENSIONER DID NOT OPEN BECAUSE IT WAS JAMMED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM A DIFFRENT MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183906 ↗
• MalfunctionAug 23, 2024Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE LOST FUNCTIONALITY. NO FURTHER INFORMATION WAS RECEIVED. UPDATE SWIT 24-JUL-2024: FURTHER INFORMATION WAS PROVIDED THAT THE TIP GOT BLOCKED AND LOADING OF A K-WIRE WAS NOT POSSIBLE. A NEW PIN DRIVER WAS USED TO FINISH THE SURGERY SUCCESSFULLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048589 ↗
• MalfunctionMay 6, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE DRILL LINING OF THE DEVICE IS DEFECTIVE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250989 ↗
• MalfunctionAug 25, 2023Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-400PD PIN DRIVER ATTACHMENT WILL NOT HOLD ANYTHING INSIDE THE CLASP. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17622628 ↗
• MalfunctionJul 28, 2023Fitting Problem; Fitting Problem

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-400PD PIN DRIVER ATTACHMENTS OPENING WHERE PINS ARE HELD IS LOOSE, NOT HOLDING PINS TIGHTLY IN PLACE. DISCOVERED DURING A CASE. NO PATIENT HARM. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17418553 ↗
• MalfunctionMay 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE HAS METAL ABRASION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 04-MAY-2023 (B)(6): FURTHER INFORMATION REVEALED THAT THIS INCIDENT OCCURRED DURING AN OSTEOSYNTHESIS FOR RADIAL HEAD AND CROWN PROCESS FRACTURE AT THE LEFT ELBOW. THE METAL ABRASION OCCURRED FROM THE CLAMPING FIXTURE FOR KIRSCHNER WIRES. CLEARLY VISIBLE METAL PARTICLES FELL INTO THE SURGICAL SITE, BUT THESE COULD BE COMPLETELY REMOVED MACROSCOPICALLY BY MECHANICAL CLEANING/RINSING. APART FROM THE SLIGHT PROLONGATION OF THE OPERATING TIME (LESS THAN 15 MINUTES), THERE WERE NO DAMAGE/NEGATIVE CONSEQUENCES FOR THE PATIENT. 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 05-MAY-2023 (B)(6): FURTHER INFORMATION REVEALED, THAT THE SURGEON WAS NOT AWARE AT THIS TIME THAT THE PARTICLES ARE METAL ABRASIONS. THE SURGEON THOUGHT THE PARTICLES WERE DRIED BLOOD, BUT THE SURGICAL SITE WAS RINSED OUT TO MAKE SURE NOTHING REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017770 ↗
• MalfunctionMay 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION OF A COMPLEX PIPKIN IV DISLOCATION FRACTURE OF THE LEFT HIP JOINT THE DEVICE HAS METAL ABRASION. THE METAL ABRASION OCCURRED FROM THE CLAMPING FIXTURE FOR KIRSCHNER WIRES. CLEARLY VISIBLE METAL PARTICLES FELL INTO THE SURGICAL SITE, BUT THESE COULD BE COMPLETELY REMOVED MACROSCOPICALLY BY MECHANICAL CLEANING/RINSING. APART FROM THE SLIGHT PROLONGATION OF THE OPERATING TIME (LESS THAN 15 MINUTES), THERE WERE NO DAMAGE/NEGATIVE CONSEQUENCES FOR THE PATIENT. 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. 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 17017765 ↗