NA 03.010.442Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982068842), received between Mar 2, 2017 and Jul 16, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (2 reports).

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 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.

• MalfunctionJul 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, DURING DRILLING FOR PROXIMAL UNKNOWN SCREWS, THE DRILL BIT WAS CONTACTED NAIL AND WITH AN UNKNOWN ISSUE. THE SURGEON SUCCESSFULLY PASSED THE UNKNOWN SCREW AND AFTER THE SURGERY, THE GUIDE/ DRILL SLEEVE LINED UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 12.0/8.0MM PROTECTION SLEEVE WITH FLATS FOR SUPRAPATELLAR. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10285961 ↗
• MalfunctionFeb 8, 2019Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ORTHOPEDIC PROCEDURE, THE DRIVING CAP BROKE INSIDE THE INSERTION HANDLE FOR SUPRAPATELLAR WHICH CAUSED THE DOCTOR TO HAVE TO STRIKE THE HANDLE WHICH CAUSED THE SCREW TO MISS THE NAIL BUT WAS ABLE TO FREE HAND LOCK THE HOLE WITHOUT ANY FURTHER INCIDENTS. THE AIMING ARM FOR SUPRATELLAR AND PROTECTION SLEEVE WERE ALSO DAMAGED. THERE WERE NO FRAGMENTS GENERATED FROM BROKEN DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 12.0/8.0MM PROTECTION SLEEVE WITH FLATS FOR SUPRAPATELLAR. THIS REPORT IS 5 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8321780 ↗
• MalfunctionMar 2, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT WHILE PERFORMING A SUPRAPATELLAR TIBIAL NAILING PROCEDURE THE SURGEON HAD INSERTED THE TIBIAL NAIL AND WHILE ATTEMPTING TO DRILL FOR THE PROXIMAL INTERLOCKING SCREWS, THE DRILL BIT HIT THE NAIL. THE SURGEON WAS CONCERNED THERE WAS AN ALIGNMENT ISSUE WITH THE SYNTHES AIMING DEVICES. THE SURGEON THEN ATTEMPTED TO DRILL FOR ANOTHER INTERLOCKING SCREW AND WAS SUCCESSFUL. UPON ADDRESSING THE PREVIOUS SCREW, SHE ATTEMPTED TO DRILL AGAIN AND WAS SUCCESSFUL IN DRILLING AND PLACING THE SCREW. THE PATIENT ALSO HAD A DISTAL FIBULA FRACTURE. WHILE TRYING TO PLACE A BONE CLAMP AROUND THE FRACTURE, ONE TIP OF THE REDUCTION FORCEPS BROKE OFF. THE FRAGMENT WAS RETRIEVED AND DISCARDED. THERE WAS A TWO (2) MINUTE DELAY DUE TO THE REPORTED EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER CLAMP. THE PATIENT POSTSURGICAL OUTCOME WAS REPORTEDLY FINE. CONCOMITANT DEVICES REPORTED: TIBIAL NAIL (PART #UNKNOWN, LOT # UNKNOWN, QUANTITY 1), DRILL BIT (PART #UNKNOWN LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6371100 ↗

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