NA 357.128Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982195876), received between Aug 16, 2019 and Aug 24, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, 12.0MM/8.0MM PROTECTION SLEEVE WAS BENT AND WILL NOT ACCOMMODATE THE INNER DRILL SLEEVE. THE TROCAR THREADING WAS DAMAGED AND WILL NOT THREAD INTO THE OUTER 13MM TISSUE PROTECTOR. THE DRILL SLEEVE WAS BENT AND WILL NOT ACCOMMODATE THREADED SCHANTZ PINS WHICH WAS STUCK. CONCOMITANT DEVICE REPORTED: UNKNOWN INNER DRILL SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 13.0MM/3.2MM TROCAR. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358923 ↗
• MalfunctionAug 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A RETROGRADE NAIL SURGERY FOR A MIDSHAFT FEMUR FRACTURE ON (B)(6) 2019, A PROTECTION SLEEVE WAS SLID WITH THE TROCAR AND SCREWED IN OVER AN UNKNOWN GUIDE WIRE AFTER FINDING THE ENTRY POINT. WHEN THE SURGEON TRIED TO UNSCREW THE TROCAR SO HE COULD OPEN THE CANAL WITH AN UNKNOWN REAMER, THE TROCAR WOULD NOT UNSCREW. THUS, THE SURGEON HAD TO PULL THE WHOLE GUIDE WIRE OUT AND LOOSEN THE TROCAR AND SLIDE IT BACK OVER THE GUIDE WIRE. THE SURGEON WAS STILL ABLE TO COMPLETE THE SURGERY USING THE SAME INSTRUMENTS WITH THE PATIENT IN GOOD CONDITION. THERE WAS A SURGICAL DELAY OF 30 SECONDS WITH NO HARM TO THE PATIENT. CONCOMITANT DEVICE/S REPORTED: UNKNOWN GUIDE WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). UNKNOWN REAMER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE 13.0 MM /3.2 MM TROCAR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8902661 ↗