NA 391.952Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587041001), received between Mar 29, 2017 and Mar 18, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE MESH CUTTER WAS NOT CUTTING CORRECTLY, AND IT HAS A CRACK IN IT. THERE WAS NO REPORT OF PATIENT OR PROCEDURE INVOLVEMENT. UPON VISUAL INSPECTION OF THE RETURNED DEVICE, THE CUTTING FEATURE WAS OBSERVED TO BE BROKEN AND NOT RETURNED. THIS REPORT IS FOR A MESH CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516665 ↗
• MalfunctionOct 20, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2020, AN INVENTORY CHECK OCCURRED AND MULTIPLE DEVICES INCLUDING A MESH CUTTER, RIGHT ANGLE BENDER, PLATE CUTTER, 90 DEGREE SCREWDRIVER T-HANDLE, HANDLE FOR 90° SCREWDRIVER, SHAFT FOR 90° SCREWDRIVER, AND MATRIXRIB SCREWDRIVER BLADE SELF-RETAINING F/90° SCREWDRIVER WERE FOUND WITH MALFUNCTIONS. WHEN TESTED, THE DEVICES WOULD NOT WORK PROPERLY. THEY WOULD NOT TURN, HOLD SCREWS, AND SOME WERE STRIPPED. SOME INSTRUMENTS WERE BENT OR DULL. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) MESH CUTTER. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10706281 ↗
• MalfunctionMay 15, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A MESH CUTTER WAS DISCOVERED TO BE BROKEN. ANOTHER SET WAS OPENED AND USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A MESH CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10062428 ↗
• MalfunctionMar 29, 2017Break; Break

  (B)(6) REPORTED THE FOLLOWING EVENT: DURING AN UNKNOWN SURGERY ON (B)(6) 2017, A SMALL PIECE OF THE END OF THE MESH CUTTER BROKE OFF. IT WAS REPORTED THAT THE PIECE WAS RETRIEVED AND NO FRAGMENTS REMAIN IN THE PATIENT. THERE WAS NO DELAY IN SURGERY AS THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PATIENT WAS REPORTED AS STABLE AND THE SURGERY COMPLETED SUCCESSFULLY. THIS COMPLAINT IS FOR ONE DEVICE. CONCOMITANT DEVICE: MESH (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6443271 ↗