Arsenal Foot 300-82-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810028390096), received between Mar 10, 2021 and Jun 15, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2021Off-Label Use; Off-Label Use

  ON (B)(6) 2021, A TRILLIANT SURGICAL INDEPENDENT SALES REPRESENTATIVE EMAILED TWO (2) DJO F&A SALES SUPPORT SPECIALISTS TO REPORT A REMOVAL OF A 300-82-002 (ARSENAL PETITE MPJ PLATE, R) AND ASSOCIATED HARDWARE AT FACILITY 1 WITH DOCTOR 1 ON A (B)(6) MALE ON (B)(6) 2021. IN THE SALES REPRESENTATIVE'S EMAIL, HE STATED THAT THE PATIENT WAS NON-COMPLIANT, DIABETIC, AND THE SURGICAL SITE WAS INFECTED. THE ENTIRE CONSTRUCT WAS REMOVED AND THE 1ST MPJ WAS AMPUTATED BY DOCTOR 1. THE ENTIRE CONSTRUCT WAS RETAINED BY THE FACILITY AND WILL NOT BE RETURNED TO CORPORATE FOR FURTHER REVIEW. A FOLLOW UP EMAIL WAS SENT TO THE SALES REPRESENTATIVE ON (B)(6) 2021 TO OBTAIN FURTHER DETAILS ABOUT THE ASSOCIATED HARDWARE, PATIENT INFORMATION, AND IMPLANTATION SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 12000056 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 04/30/2021, A TRILLIANT SURGICAL INDEPENDENT SALES REPRESENTATIVE CALLED A TRILLIANT SURGICAL SALES SUPPORT SPECIALIST TO REPORT OF A REMOVAL OF A 300-82-002 (ARSENAL PETITE MPJ PLATE, R) AND ASSOCIATED SCREWS DUE TO A PATIENT REPORTING LOCALIZED PAIN. THE REMOVAL OCCURRED AT FACILITY 1 BY DOCTOR 1 ON A (B)(6) YEAR-OLD MALE PATIENT WITH AVERAGE BONE QUALITY. IT IS TO BE NOTED THAT DOCTOR 1 OBSERVED THAT THERE WAS NO INFECTION AT THE SITE, BUT FUSION DID NOT OCCUR. THE ENTIRE PLATE CONSTRUCT WAS REMOVED, WHICH INCLUDED 300-82-002 (ARSENAL PETITE MPJ PLATE, R), 200-30-036 (3.0MM X 36MM TIGER CANNULATED SCREW), 308-35-016 (3.5MM X 16MM ARSENAL LOCKING SCREW), 308-35-018(3.5MM X 18MM ARSENAL LOCKING SCREW), AND 307-35-020 (3.5MM X 20MM ARSENAL SCREW). DOCTOR 1 OPTED TO LEAVE THE SURGICAL SITE AS IS AND DID NOT RE-PLATE DURING THE REMOVAL SURGERY. THE SALES REPRESENTATIVE NOTED THAT THE ORIGINAL IMPLANTATION OCCURRED ON 11/10/2020 AT FACILITY 2 WITH DOCTOR 1 AND THE SURGERY WAS COMPLETED SUCCESSFULLY THEN. THE ENTIRE PLATE CONSTRUCT WAS RETAINED BY THE FACILITY AND WILL NOT BE RETURNED TO CORPORATE FOR FURTHER REVIEW.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 11901105 ↗
• InjuryMar 10, 2021Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED 03/11/2021: ADDITIONAL INFORMATION WAS RECEIVED FOR CCR 21-02-006 BY [SALES REPRESENTATIVE] ON 03/11/2021 REGARDING THE FAILURE OF A 300-82-002 (ARSENAL PETITE MPJ PLATE, RIGHT) BREAKING POST-OPERATIVE OF THE (B)(6) 2020 IMPLANTATION DATE. THE PATIENT WAS 5'5", WEIGHING 160 POUNDS. SHE REPORTED EVERYTHING FELT GREAT FOLLOWING POST-OP UNTIL (B)(6) OF 2021, THIS IS WHEN THE PATIENT BEGAN EXPERIENCING PAIN, WHICH WAS FOLLOWED UP WITH A (B)(6) 2021 APPOINTMENT WITH DOCTOR 1 WHERE THE BROKEN PLATE WAS DISCOVERED. THE INFLAMMATION SEEN ON THE PROVIDED X-RAY WAS DUE TO THE BROKEN PLATE PER DOCTOR 1 AND FUSION WAS SEEN PRIOR TO THE PLATE BREAKING. THE HARDWARE REMOVAL DATE WAS SET FOR (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 11453306 ↗