NA 03.010.443Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982068859), received between Sep 13, 2018 and Apr 21, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionApr 21, 2023Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON THURSDAY (B)(6) 2023, THAT THEY DID A SUPRAPATELLAR TIBIAL NAIL CASE AND ONE OF THE SURGEONS DECIDED TO DO SOMETHING NOT RECOMMENDED, WHICH END UP RESULTING ON A COUPLE OF INSTRUMENTS ON THE MODULE BEING DAMAGED FOR GOOD. THE 2 ITEMS CODE ARE : 03.010.443 AND 03.010.404 BOTH OF THEM ARE NOW IMPOSSIBLE TO BE SEPARATED. THIS REPORT IS FOR ONE (1) COMPRESSION TOOL F/ETN F/SUPRAPAT APPROACH THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16787313 ↗
• MalfunctionDec 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE COMPRESSION DEVICE FOR SUPRAPATELLAR, EXTRACTOR, CONNECTING SCREWS AND EXTRACTION SCREW WERE STRIPPED, TROCARS WERE BENT ALONG WITH THE WIRE GUIDES, BLUE HANDLE, BLACK KNOB BROKE OFF, ALONG WITH BUTTONS ON THE SIDE TO PROTECTION SLEEVE. THE SURGEON WAS AGGRESSIVE AND OVER-TORQUED PRODUCTS LEADING TO STRIPPING AND BENDING OF PRODUCTS. A NEW SET BROUGHT INTO THE ROOM. THERE WERE 10 MINUTES OF SURGICAL DELAY. IT IS UNKNOWN IF THE SURGERY SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) COMPRESSION DEVICE FOR SUPRAPATELLAR THIS REPORT IS 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072167 ↗
• MalfunctionSep 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE COMPRESSION DEVICE AND CONNECTION SCREW STUCK TOGETHER AND WERE UNABLE TO BE SEPARATED. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A COMPRESSION DEVICE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7874052 ↗