NA 03.010.438SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982068798), received between Nov 6, 2020 and Sep 17, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT ON SEPT 1ST, DURING A PROCEDURE, THE 12MM OPENING DRILL BIT WAS USED WITH THE 14.5MM SUPRAPATELLAR OUTER PROTECTION SLEEVE WITHOUT THE USE OF THE METAL 14.5MM PROTECTION SLEEVE. AFTER THE NAIL WAS IMPLANTED LOCKED WITH LOCKING SCREWS, INSERTION/AIMING INSTRUMENTATION WAS REMOVED. UPON REMOVAL OF THE INSTRUMENTATION, IT WAS DISCOVERED THAT THE SUPRAPATELLAR OUTER PROTECTION SLEEVE WAS DAMAGED. A 5MMX10MM PIECE WAS MISSING FROM THE SLEEVE. THE KNEE JOINT WAS THEN INSPECTED AND SWEPT FOR ANY DEBRIS. AFTER INSPECTION OF THE KNEE JOINT, FINAL X RAYS WERE TAKEN AND INCISION CLOSURE FOLLOWED THEREAFTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20237692 ↗
• MalfunctionAug 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PIN HAD FALLEN OUT OF THE TNA DRIVING CAP. DURING THE PROCEDURE, A TNA NAIL WAS INSERTED, BUT THEN REMOVED TO DIAL IN THE REDUCTION. WHEN THE NAIL WAS EXTRACTED, IT WAS NOTICED THAT THE POLY INSERTED DISTALLY HAD MOVED OUTSIDE OF THE NAIL, THE SURGICAL TECH WAS NOT ABLE TO PUT BACK INTO THE NAIL, AND A NEW NAIL WAS SELECTED. THIS NAIL WAS ALSO EXTRACTED FOR REPOSITIONING AND THE SLEEVE HAD MOVED AS WELL, BUT SURGEON DECIDED TO MOVE FORWARD AND DRILL THROUGH THE POLY INSERT.ADDITIONALLY, THE SURGEON WAS HAVING ISSUES INSERTING THE NAIL THROUGH THE SUPRAPATELLAR PROTECTION SLEEVE, SO IT WAS REMOVED AND THE NAIL WAS INSERTED WITHOUT THE SLEEVE. DURING THE SURGERY, THE SURGEON USED A DRILL BIT IN A ¿BLOCKING¿ FASHION TO REDIRECT THE NAIL, BUT THE DRILL BIT WAS UNABLE TO REMAIN STABLE BECAUSE OF THE COMMINUTION. THEN A BLOCKING SCREW WAS USED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE.THIS REPORT IS FOR A 14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR ¿ STERILE.THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548588 ↗
• InjuryNov 6, 2020Break; Break

  IT WAS REPORTED THAT DURING A SUPRAPATELLAR NAILING ON (B)(6) 2020, PART OF THE PROTECTION SLEEVE WAS EITHER REAMED OR CUT. THE SURGEON NEEDED TO OPEN THE PATIENT FURTHER TO RETRIEVE THE PIECE. IT WAS ALSO REPORTED THAT THE SCREW MISSED THE NAIL THROUGH THE AIMING ARM. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF THIRTY (30) MINUTES. PATIENT STATUS WAS VERY GOOD. THIS REPORT IS FOR A 14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10803423 ↗

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