NA 04.003.026SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982081568), received between Nov 5, 2018 and Mar 13, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K040336, K172157); 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.

• MalfunctionMar 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE APPROXIMATELY 3.5 YEARS AGO, THE PATIENT UNDERWENT IMPLANT OF A FEMORAL NAIL/A2FN. ON (B)(6) 2024 FOLLOWING REMOVAL OF THE NAIL IMPLANT, THE MOST PROXIMAL HIP SCREW WAS ATTEMPTED TO BE REMOVED BUT IT STOOD STILL. THE SURROUNDING TISSUE AND CALLUS WERE REMOVED BUT THE SCREW IN QUESTION WOULD NOT TURN. AFTER THAT, THE DISTAL HIP SCREW, DISTAL LOCKING SCREW AND END CAP WERE EXTRACTED. THERE WERE CONTINUED ATTEMPTS TO REMOVE THE SCREW IN QUESTION BUT IT WAS STILL UNSUCCESSFUL, A DIFFERENT SCREWDRIVER WAS USED AND FORCEPS WERE USED, BUT REMOVAL COULD NOT BE ACHIEVED. BECAUSE OF THE ATTEMPTS TO REMOVE THE SCREW, SURGICAL TIME WAS EXTENDED FOR 3 HOURS. ULTIMATELY THE PROCEDURE ENDED WITH WOUND CLOSURE. THE PATIENT OUTCOME WAS STABLE. ON (B)(6) 2024 EXTRACTION SURGERY WAS SUCCESSFULLY PERFORMED AS BONE FUSION WAS ACHIEVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 6.5MM TI RECON SCREW WITH T25 STARDRIVE 80MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895469 ↗
• InjuryNov 5, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, ONE (1) TITANIUM FEMORAL RECON NAIL CANNULATED, AND TWO (2) TITANIUM RECON SCREWS DID NOT FUNCTION PROPERLY. THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE REGARDING ENTRY POINT AND INTRAMEDULLARY REAMING. THE SURGEON IMPLANTED THE FEMORAL RECON NAIL BUT IT WAS DIFFICULT TO MALLET THE NAIL INTO THE FEMUR. ONCE THE NAIL WAS SEATED, HE TRIED TO ROTATE THE NAIL USING THE AIMING ARM AND IT WOULD NOT ROTATE. HE THEN BACK SLAPPED THE NAIL, SO IT COULD BE INSERTED WITH MORE ANTI-VERSION, BUT IT WAS VERY DIFFICULT TO INSERT. AFTER THIS, IT WAS MADE SURE THAT THE CANNULATED CONNECTING SCREW WAS SECURE AND TIGHT. ONCE THE NAIL WAS BACK SLAPPED ENOUGH, HE CORRECTED THE ANTI-VERSION AND MALLETED THE FEMORAL RECON NAIL BACK DOWN THE FEMUR. THE CANNULATED CONNECTING SCREW WAS CHECKED ONCE MORE TO MAKE SURE IT WAS SECURE AND TIGHT. THE SURGEON THEN AGAIN STARTED THE PROXIMAL RECON SCREW IMPLANTATION PROCESS, AND THE NAIL WAS STILL AIMING TOO POSTERIOR. THE SURGEON THEN TRIED TO CHANGE THE ROTATION OF THE NAIL BY ROTATING THE AIMING ARM. HE THOUGHT HE WAS IN THE RIGHT POSITION BUT, AFTER COMPLETING THE IMPLANTATION OF THE FEMORAL RECON

  Patient problems: No Code Available

  MAUDE report 8037759 ↗
• InjuryNov 5, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, ONE (1) TITANIUM FEMORAL RECON NAIL CANNULATED, AND TWO (2) TITANIUM RECON SCREWS DID NOT FUNCTION PROPERLY. THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE REGARDING ENTRY POINT AND INTRAMEDULLARY REAMING. THE SURGEON IMPLANTED THE FEMORAL RECON NAIL BUT IT WAS DIFFICULT TO MALLET THE NAIL INTO THE FEMUR. ONCE THE NAIL WAS SEATED, HE TRIED TO ROTATE THE NAIL USING THE AIMING ARM AND IT WOULD NOT ROTATE. HE THEN BACK SLAPPED THE NAIL, SO IT COULD BE INSERTED WITH MORE ANTI-VERSION, BUT IT WAS VERY DIFFICULT TO INSERT. AFTER THIS, IT WAS MADE SURE THAT THE CANNULATED CONNECTING SCREW WAS SECURE AND TIGHT. ONCE THE NAIL WAS BACK SLAPPED ENOUGH, HE CORRECTED THE ANTI-VERSION AND MALLETED THE FEMORAL RECON NAIL BACK DOWN THE FEMUR. THE CANNULATED CONNECTING SCREW WAS CHECKED ONCE MORE TO MAKE SURE IT WAS SECURE AND TIGHT. THE SURGEON THEN AGAIN STARTED THE PROXIMAL RECON SCREW IMPLANTATION PROCESS, AND THE NAIL WAS STILL AIMING TOO POSTERIOR. THE SURGEON THEN TRIED TO CHANGE THE ROTATION OF THE NAIL BY ROTATING THE AIMING ARM. HE THOUGHT HE WAS IN THE RIGHT POSITION BUT, AFTER COMPLETING THE IMPLANTATION OF THE FEMORAL RECON

  Patient problems: No Code Available

  MAUDE report 8037755 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040336, K172157. One submission often covers many models, so check the product and lot details in each record.

• Z-1915-2015 · May 27, 2015 · Terminated
  DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Sub
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.