NA 03.211.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982076052), received between Aug 3, 2018 and May 2, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2024Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICES WERE UNABLE TO STERILIZE/ASSEMBLE. IT WAS ALSO REPORTED THAT THE DEVICES HAD CHIPPING/CRACKING AND UNABLE TO BE USE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MESH PLATE CUTTERS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234952 ↗
• MalfunctionOct 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 THE INSTRUMENT WAS BROKEN. THE PLATE CUTTER WAS FOUND BROKEN IN SET .THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME: PATIENT FINE. THIS REPORT IS FOR ONE (1) MESH PLATE CUTTERS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887718 ↗
• MalfunctionSep 22, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, UPON INSPECTION OF THE DEVICE, IT WAS FOUND TO HAVE A BROKEN TOP HINGE OF THE PLATE CUTTER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE MESH PLATE CUTTERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799780 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED ON (B)(6)2022 ,SURGEON USING MESH PLATE CUTTER. ONE OF THE POSTS ON CUTTER BROKE OFF. THE SURGERY WAS THEN COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) MESH PLATE CUTTERS THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607415 ↗
• MalfunctionOct 4, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE ONE OF THE ACCOUNTS INFORMED US THAT THE MESH PLATE CUTTER FROM THEIR MIDFOOT/FOREFOOT SET WAS BROKEN. THE EVENT OCCURRED POST-OP AND THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS FOR ONE MESH PLATE CUTTERS. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540633 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A MESH PLATE CUTTER WAS DISMANTLED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) MESH PLATE CUTTERS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865235 ↗
• MalfunctionFeb 28, 2022Break; Break

  THE MESH PLATE CUTTERS (03.211.007) BROKE AFTER SINGLE USE ON THE 2.4 MM / 2.7 MM VA-LCP MESH PLATE (02.211.224) DURING A FOOT SURGERY ON (B)(6) 2022. THE CUSTOMER JUST PURCHASED THE MESH PLATE CUTTERS AND IS FRUSTRATED THEY BROKE AFTER SINGLE USE. THE NUB THAT IS INSERTED INTO THE LOCKING HOLE SNAPPED OFF WHEN APPLYING TENSION. THIS REPORT IS FOR ONE (1) MESH PLATE CUTTERS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13618880 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS BROKE DUE TO USAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) MESH PLATE CUTTERS. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543674 ↗
• InjurySep 16, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE PLATE CUTTER WAS BROKE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. FRAGMENTS WERE GENERATED AND NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - PLATES: MESH IMPLANT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) MESH PLATE CUTTERS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12483035 ↗
• MalfunctionFeb 24, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE METAL PORTION OF THE MESH PLATE CUTTERS HAS BROKEN DURING THE STERILE PROCESSING AFTER A CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE MESH PLATE CUTTERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9744877 ↗
• MalfunctionApr 10, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2019, THE MESH PLATE CUTTER WAS DISCOVERED BROKEN FROM THE VARIABLE ANGLE LOCKING COMPRESSION PLATE FOREFOOT MIDFOOT SYSTEM SET. REPORTEDLY, THIS DID NOT AFFECT THE SURGERY AND THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) MESH PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500623 ↗
• MalfunctionAug 3, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION IN THE STERILE PROCESSING DEPARTMENT (SPD), THE TIP OF THE STARDRIVE SCREWDRIVER SHAFT WAS OBSERVED TO BE TWISTED AND ALSO A MESH PLATE CUTTERS WAS DISCOVERED TO BE BROKEN WHILE THE SALES CONSULTANT WAS SETTING UP THE TRAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MESH PLATE CUTTERS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7748953 ↗