Arthrex® AR-4151DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867032781), received between Mar 31, 2017 and Jun 4, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Break; Break

  ON 12/20/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-4151DS TRIM-IT DRILL PIN DISPOSABLES KIT DID NOT PROVIDE THE PROPER ROTATIONAL STABILITY AS IT SNAPPED UPON MANIPULATION. CASE WAS COMPLETED USING A 2MM PIN INSTEAD. THIS WAS DISCOVERED DURING A FUSION 3RD PHALANGE PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 12/22/2022: THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457391 ↗
• InjuryMay 23, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  A PATIENT HAS REPORTED THROUGH THE ARTHREX WEBSITE THAT SHE HAD UNDERGONE SURGERY IN (B)(6) 2018 DURING WHICH A TRIM-IT PIN WAS IMPLANTED. PATIENT STATES SHE HAS AN ALLERGY TO ACRYLIC POLYMERS AND WAS INQUIRING AS TO THE MATERIAL COMPOSITION OF THE IMPLANT. SPECIFIC ARTHREX PART NUMBER WAS NOT PROVIDED. PATIENT STATES THE DEVICE MAY BE CAUSING A DELAYED FOREIGN BODY REACTION IN THE TOES THAT THE SURGERY WAS PERFORMED ON. ADDITIONAL INFORMATION PROVIDED 4/29/2019: DATE OF SURGERY WAS (B)(6) 2018. SURGERY WAS A HAMMER TOE PROCEDURE OF MIDDLE TOE/RIGHT FOOT. PATIENT ISSUES FIRST BEGAN IN (B)(6) 2018. DURING THE 9/19/18 PROCEDURE AN ARTHREX AR-4151DS TRIM IT PIN WAS IMPLANTED. SYMPTOMS INCLUDE SWELLING, REDNESS, PAIN WHICH GENERATES FROM PATIENT TOE TO HER CALF. TO DATE SHE HAS BEEN TREATED WITH CORTISONE SHOTS. PATIENT IS BEING PROVIDED WITH THE MATERIAL COMPOSITION OF THE DEVICE AS REQUESTED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Pain; Swelling

  MAUDE report 8636768 ↗
• InjuryNov 1, 2018Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN, SWELLING AND A REPORTED INFECTION SINCE A TRIM IT PIN WAS IMPLANTED IN (B)(6) 2016. THE REP STATED THAT THE TRIM IT PIN WAS IMPLANTED FOR A HAMMERTOE CORRECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 10/10/2018: THE REP CONFIRMED THAT THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2016. THE ORIGINAL PROCEDURE WAS A HAMMERTOE CORRECTION PROCEDURE ON TOES, 2, 3, AND 4. THE FOLLOWING PART AND LOT NUMBERS WERE IMPLANTED DURING THE ORIGINAL (B)(6) 2016 PROCEDURE: AR-4151DS: LOT: 10048351 / QTY. 2. AR-4151DS: LOT: 10029027 / QTY. 1. THE REP STATED THEY ARE NOT AWARE OF THE SPECIFIC DATE OF WHEN THE PATIENT STARTED EXPERIENCING PAIN, SWELLING, DISCOMFORT, AND REPORTED INFECTION. THE REP REPORTED THAT THEY WERE NOT GIVEN ANY SPECIFICS ON TYPE OF INFECTION, OR IF THERE HAS BEEN TESTING DONE. THERE ARE NOT ANY DETAILS ON CURRENT TREATMENT FOR THE PATIENT'S REPORTED INFECTION AND SYMPTOMS. THE REP STATED THAT THE SAME SURGEON WHO PERFORMED THE ORIGINAL PROCEDURE DOES PLAN TO REMOVE THE PIN AT THE SAME LOCATION OF THE ORIGINAL SURGERY. THE REP CONFIRMED THAT AS OF NOW THERE HAS NOT BEEN A REMOVAL SURGERY

  Patient problems: Discomfort; Pain; Swelling; Unspecified Infection

  MAUDE report 8030510 ↗
• InjuryNov 1, 2018Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN, SWELLING AND A REPORTED INFECTION SINCE A TRIM IT PIN WAS IMPLANTED IN (B)(6) 2016. THE REP STATED THAT THE TRIM IT PIN WAS IMPLANTED FOR A HAMMERTOE CORRECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 10/10/2018: THE REP CONFIRMED THAT THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2016. THE ORIGINAL PROCEDURE WAS A HAMMERTOE CORRECTION PROCEDURE ON TOES, 2, 3, AND 4. THE FOLLOWING PART AND LOT NUMBERS WERE IMPLANTED DURING THE ORIGINAL (B)(6) 2016 PROCEDURE: AR-4151DS: LOT: 10048351 / QTY. 2; AR-4151DS: LOT: 10029027 / QTY. 1. THE REP STATED THEY ARE NOT AWARE OF THE SPECIFIC DATE OF WHEN THE PATIENT STARTED EXPERIENCING PAIN, SWELLING, DISCOMFORT, AND REPORTED INFECTION. THE REP REPORTED THAT THEY WERE NOT GIVEN ANY SPECIFICS ON TYPE OF INFECTION, OR IF THERE HAS BEEN TESTING DONE. THERE ARE NOT ANY DETAILS ON CURRENT TREATMENT FOR THE PATIENT'S REPORTED INFECTION AND SYMPTOMS. THE REP STATED THAT THE SAME SURGEON WHO PERFORMED THE ORIGINAL PROCEDURE DOES PLAN TO REMOVE THE PIN AT THE SAME LOCATION OF THE ORIGINAL SURGERY. THE REP CONFIRMED THAT AS OF NOW THERE HAS NOT BEEN A REMOVAL SURGERY

  Patient problems: Discomfort; Pain; Swelling; Unspecified Infection

  MAUDE report 8030496 ↗
• InjuryDec 11, 2017Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HAMMERTOE REPAIR PROCEDURE ON HER RIGHT FOURTH TOE ON (B)(6) 2017, USING TRIM IT PINS. THE PIN DID NOT PERFORM AS IT SHOULD, AND SHE HAD TO DO A SECOND SURGERY ON (B)(6) 2017 TO REMOVE THE PIN. NO FURTHER DETAILS PROVIDED AT TIME OF INITIAL REPORT. FOLLOW-UP INVESTIGATION FROM MEDICAL RECORDS: OP REPORT (B)(6) 2017 PROCEDURE: THE PATIENT IMPLANT WAS AN AR-4151DS, IMPLANT DELIVERY SYSTEM, TRIM-IT DRILL PIN 1.5X 100 MM. PATIENT DIAGNOSIS WHICH LED TO THE (B)(6) 2017 PROCEDURE WAS RIGHT FOURTH DIGIT HAMMERTOE. PATIENT (B)(6) AT TIME OF REVISION. (B)(6) LBS. HEIGHT (B)(6) INCHES, (B)(6). OP REPORT (B)(6) 2017 PROCEDURE: ON (B)(6) 2017 PATIENT UNDERWENT A REVISION SURGERY DUE TO PAINFUL RETAINED INTERNAL FIXATIVE, DEEP RIGHT 4TH DIGIT. EXTENSIVE DISSECTION WAS NEEDED TO REMOVE THE TRIM-IT PIN. IT WAS NECESSARY TO CUT THE TRIM-IT PIN AT THE LEVEL OF THE DISTAL INTERPHALANGEAL JOINT AND THEN IT WAS REMOVED PROXIMALLY AND DISTALLY. THE PROXIMAL PORTION WAS FOUND TO BE IN AN ODD SHAPE AND ONE PORTION WAS FOUND TO BE IN A U SHAPE. THE SECOND SMALL FRAGMENT WAS REMOVED DISTALLY AND THE ENTIRE PIECE MEASURED 3 CM WHICH WAS FELT TO BE THE ENTIRE LENG

  Patient problems: Foreign Body In Patient

  MAUDE report 7105364 ↗
• InjuryMar 31, 2017Migration or Expulsion of Device; Material Protrusion/Extrusion

  IT WAS REPORTED BY PATIENT THAT SHE HAD SURGERY ON (B)(6) 2015 FOR THE FOLLOWING PROCEDURES: RIGHT AUSTIN BUNIONECTOMY, SECOND TOE ARTHRODESIS, SECOND METATARSOPHALANGEAL JOINT RELEASE, AND TAILOR'S BUNION EXOSTECTOMY. DURING THE PROCEDURE, AN ARTHREX AR-4151DS, IMPLANT DELIVERY SYSTEM, TRIM-IT DRILL PIN, 1.5MM X 100MM WAS IMPLANTED. PATIENT STATES THAT AFTER 14 MONTHS, THE PIN HAD NOT DEGRADED, IT HAD MIGRATED AND STARTED PROTRUDING AND CAUSE HER A LOT OF PAIN. ON (B)(6) 2016, PATIENT UNDERWENT A SECOND SURGERY TO REMOVE THE IMPLANT. WHEN PIN WAS REMOVED IT WAS FULLY INTACT WITH NO SIGNS OF HAVING BEGUN TO DEGRADE.

  Patient problems: Pain

  MAUDE report 6449705 ↗