NA 03.010.456Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982068910), received between Dec 24, 2020 and Dec 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K111667); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2020Material Deformation; Material Deformation

  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) 14.5MM TROCAR/PEEK FOR SUPRAPATELLAR. THIS REPORT IS 4 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072164 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111667. One submission often covers many models, so check the product and lot details in each record.

• Z-0404-2014 · Oct 14, 2013 · Terminated
  Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabil