NA 314.164Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982188632), received between Jun 8, 2017 and Sep 11, 2023 — classified as 4 malfunctions.

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

• MalfunctionSep 11, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THERE WAS NO REMOVAL/ REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719639 ↗
• MalfunctionNov 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT SCREW RECESSES DAMAGED WHEN REMOVING TWO SCREWS. NO PATIENT CONSEQUENCE. THIS IS ALL INFORMATION WE DO HAVE SO FAR. CONCOMITANT PARTS REPORTED: 2X UNKNOWN SCREWS, PART UNKNOWN, LOT UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068664 ↗
• MalfunctionNov 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT SCREW RECESSES DAMAGED WHEN REMOVING TWO SCREWS. NO PATIENT CONSEQUENCE. THIS IS ALL INFORMATION WE DO HAVE SO FAR. CONCOMITANT PARTS REPORTED: 2X UNKNOWN SCREWS, PART UNKNOWN, LOT UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068351 ↗
• MalfunctionJun 8, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWDRIVER IS BROKEN DURING SURGERY. IT BROKE INTO THE SCREW AND THEY COULDN¿T TAKE OUT THIS PIECE FROM THE SCREW. FRAGMENTS WERE GENERATED. PROCEDURE SUCCESSFULLY COMPLETED. NO DELAY TO SURGERY TIME. NO PATIENT HARM. THIS COMPLAINT INVOLVES ONE PART. CONCOMITANT PARTS REPORTED: 1X UNK SCREW, PART UNK, LOT UNK. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6622866 ↗