Arthrex® AR-4152DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867032811), received between Aug 30, 2017 and Mar 2, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Patient Device Interaction Problem

  ON 10-FEB-2026, IT WAS REPORTED BY A HEALTH CARE PROVIDER VIA (B)(4) THAT A PATIENT WITH AN AR-4152DS TRIM-IT DRILL PIN IS SUSPECTED TO HAVE A METAL REACTION TO THE PRODUCT IMPLANTED ON (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED ON 16-FEB-2026: IT WAS FURTHER REPORTED THE PATIENT UNDERWENT A HAMMERTOE AND NEUROMA CORRECTION. SINCE (B)(6) 2024, THE TOE HAS REMAINED SWOLLEN (CONFIRMED ON A RECENT MRI). THE PATIENT REPORTS ONGOING DISCOMFORT WITH UNUSUAL SENSATIONS, INCLUDING A ¿ZINGING¿ FEELING. THE TREATING PODIATRIST SUSPECTS A POSSIBLE HYPERSENSITIVITY/ALLERGIC REACTION TO THE DISSOLVABLE PIN USED IN THE PROCEDURE, WHICH HAS NOT YET DISSOLVED. MEDICAL MANAGEMENT HAS INCLUDED STEROID INJECTIONS AT THE SITE WITHOUT IMPROVEMENT. NO ARTHREX DEVICE HAS BEEN REMOVED TO DATE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24482205 ↗
• MalfunctionJun 5, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/08/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4152DS TRIM-IT DRILL PINS CLEAR PIN HAS A BUBBLE THAT WIDENED THE SHAFT AND WAS UNABLE TO FIT THROUGH THE DRILL SLEEVE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED USING A DRILL PIN THAT WAS LONG ENOUGH TO SEAT. DELAY IN CASE 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19466618 ↗
• InjuryMar 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 02/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A DOCTOR IS HAVING AN ISSUE WITH THE AR-4152DS TRIM-IT DRILL PIN SYSTEM. THE ARTHREX REP WAS JUST MADE AWARE OF THREE PATIENTS WHO EXPERIENCED OSTEOLYSIS (BONE LOSS) POST-OP AFTER HAVING HAND OR CARPEL BONE WRIST PROCEDURES FROM 2021 TO 2023. NO SPECIFIC PATIENT INFORMATION WAS MADE AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION 3/12/2024: THIS DOCTOR NO LONGER WORKS IN OUR FOOTPRINT, AND I¿M UNSURE IF HE IS STILL OPERATING. IT WAS HIS OLD PA WHO IS NOW INQUIRING ABOUT IT. THE PREVIOUS DOCTOR'S SURGERY WAS A SCAPHOLUNATE RECONSTRUCTION, AND THEN HE WOULD THROW A COUPLE OF THE AR-4152DS WIRES TO HOLD STABILITY. THE PA SAID THAT THERE HAD BEEN OSTEOLYSIS IN 3 OF THE PATIENTS ANYWHERE FROM 6 MONTHS TO 2 YEARS POST-SURGERY. NO SECOND SURGERIES WERE DONE BECAUSE OF IT.

  Patient problems: Osteolysis

  MAUDE report 18892882 ↗
• InjuryMar 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 02/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A DOCTOR IS HAVING AN ISSUE WITH THE AR-4152DS TRIM-IT DRILL PIN SYSTEM. THE ARTHREX REP WAS JUST MADE AWARE OF THREE PATIENTS WHO EXPERIENCED OSTEOLYSIS (BONE LOSS) POST-OP AFTER HAVING HAND OR CARPEL BONE WRIST PROCEDURES FROM 2021 TO 2023. NO SPECIFIC PATIENT INFORMATION WAS MADE AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION 3/12/2024: THIS DOCTOR NO LONGER WORKS IN OUR FOOTPRINT, AND I¿M UNSURE IF HE IS STILL OPERATING. IT WAS HIS OLD PA WHO IS NOW INQUIRING ABOUT IT. THE PREVIOUS DOCTOR'S SURGERY WAS A SCAPHOLUNATE RECONSTRUCTION, AND THEN HE WOULD THROW A COUPLE OF THE AR-4152DS WIRES TO HOLD STABILITY. THE PA SAID THAT THERE HAD BEEN OSTEOLYSIS IN 3 OF THE PATIENTS ANYWHERE FROM 6 MONTHS TO 2 YEARS POST-SURGERY. NO SECOND SURGERIES WERE DONE BECAUSE OF IT.

  Patient problems: Osteolysis

  MAUDE report 18892875 ↗
• MalfunctionMar 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 02/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06493014 THAT A DOCTOR IS HAVING AN ISSUE WITH THE AR-4152DS TRIM-IT DRILL PIN SYSTEM. THE ARTHREX REP WAS JUST MADE AWARE OF THREE PATIENTS WHO EXPERIENCED OSTEOLYSIS (BONE LOSS) POST-OP AFTER HAVING HAND OR CARPEL BONE WRIST PROCEDURES FROM 2021 TO 2023. NO SPECIFIC PATIENT INFORMATION WAS MADE AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION 3/12/2024 FROM ZD: THIS DOCTOR NO LONGER WORKS IN OUR FOOTPRINT, AND I¿M UNSURE IF HE IS STILL OPERATING. IT WAS HIS OLD PA WHO IS NOW INQUIRING ABOUT IT. THE PREVIOUS DOCTOR'S SURGERY WAS A SCAPHOLUNATE RECONSTRUCTION, AND THEN HE WOULD THROW A COUPLE OF THE AR-4152DS WIRES TO HOLD STABILITY. THE PA SAID THAT THERE HAD BEEN OSTEOLYSIS IN 3 OF THE PATIENTS ANYWHERE FROM 6 MONTHS TO 2 YEARS POST-SURGERY. NO SECOND SURGERIES WERE DONE BECAUSE OF IT.

  Patient problems: Osteolysis

  MAUDE report 18889089 ↗
• InjurySep 21, 2021Device Slipped

  ON (B)(6) 2021, IT WAS REPORTED BY A PATIENT VIA E-MAIL THAT AN AR-4152DS LOT:10226124 TRIM-IT DRILL PIN HAS WORKED IT'S WAS OUT THE INCISION SITE FROM THE TOP OF THE TOE. PATIENT IS SEEKING A THIRD OPINION FROM A DOCTOR. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12507086 ↗
• InjuryJul 28, 2020Delivered as Unsterile Product; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE K-WIRE WAS PUNCTURED THROUGH THE PACKAGE AND INJURED THE NURSE. DUE TO THIS EVENT, THE DEVICE BECAME UNSTERILE. THE SURGERY WAS SUCCESSFULLY FINISHED WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR PERFORM A SECOND SURGERY. SURGERY PERFORMED WAS A PIP ARTHRODESIS. UPDATE 14-JUL-2020: FOLLOWING UPDATE RECEIVED: THE WIRE HAS A PROTECTION CAP WHICH WAS PERFORATED. THE STERILE PACKAGE ITSELF WAS INTACT AND THE DEVICES INSIDE OF THE PACKAGE WERE STERILE WHEN OPENING THE OUTER PACKAGE. THE NURSE HAD A MINOR STAB WOUND THAT BLED A LITTLE. HE COULD CONTINUE TO WORK AND HAS NO ADDITIONAL COMPLAINTS.

  Patient problems: Injury

  MAUDE report 10332220 ↗
• InjuryAug 30, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY WHERE 3 TRIM-IT PINS WERE IMPLANTED INTO HER FOOT. SINCE THE ORIGINAL SURGERY, 2 OF THE 3 PINS HAVE BEEN REMOVED. INTERNAL MEDICINE DOCTOR HAS BECOME INVOLVED AS THE SURGERY HAS NOT HELPED IN RELIEVING THE ORIGINAL ISSUE. THE DATES OF THE ORIGINAL SURGERY AND REVISION SURGERY IS NOT KNOWN.

  Patient problems: No Code Available

  MAUDE report 6829568 ↗
• InjuryAug 30, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY WHERE 3 TRIM-IT PINS WERE IMPLANTED INTO HER FOOT. SINCE THE ORIGINAL SURGERY, 2 OF THE 3 PINS HAVE BEEN REMOVED. INTERNAL MEDICINE DOCTOR HAS BECOME INVOLVED AS THE SURGERY HAS NOT HELPED IN RELIEVING THE ORIGINAL ISSUE. THE DATES OF THE ORIGINAL SURGERY AND REVISION SURGERY IS NOT KNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6829567 ↗