NA 357.127Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982195869), received between Jun 24, 2019 and Oct 2, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 16, 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.

• MalfunctionOct 2, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, IT WAS IDENTIFIED THAT THE TIP OF THE SLEEVE IS DAMAGED, LOOKS LIKE IT IS BURRED. THIS INSTRUMENT IS COMPOSED OF THE ONE PART. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) 13.0MM PROTECTION SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17854173 ↗
• 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 PROTECTION SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8902664 ↗
• MalfunctionJun 24, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING DECONTAMINATION, THE PROTECTION SLEEVE WAS FOUND DEFORMED. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8728175 ↗