EXPert 03.010.482Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982069009), received between Jan 5, 2017 and May 3, 2022 — classified as 3 injuries, 2 malfunctions.

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); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY FOR THE LFN INSERTION ON (B)(6) 2022, IT WAS OBSERVED THAT THE REAMER DEVICE WAS COMING INTO CONTACT WITH THE NAIL WHEN PASSED THROUGH THE GUIDE SLEEVES INSERTED THROUGH THE AIMING ARM, AND WAS CAUSING IT TO ¿STICK¿ BEFORE PASSING THROUGH THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) AIM-ARM RADIOLUC F/EXPERT LFN DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269841 ↗
• InjuryAug 29, 2019Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  UPDATED EVENT DESCRIPTION (ADDITIONAL INFORMATION) IT WAS REPORTED THAT DURING A RECON NAIL SURGERY ON (B)(6) 2019, THE CANNULAS OF TWO (2) RADIOLUCENT RECON AIMING ARM FOR EXPERT LATERAL FEMORAL NAIL (LFN) WERE A LITTLE BIT LOOSE INSIDE. THE GUIDE WIRES FOUR (4) WAS MISSING THE RECON NAIL HOLE POSTERIOR AND ANTERIOR BY QUITE A BIT AND WAS UNABLE TO PROCEED WITH THE RECON NAIL LOCKING OPTION BECAUSE OF IT. EVEN AFTER LOCKING THE LARGEST GOLD CANNULA INTO THE RADIOLUCENT AIMING ARM, THE SURGEON AND THE SALES REP FELT AS THOUGH THERE WAS SOME "WIGGLE" ROOM OR A LITTLE BIT OF TOGGLE THAT COULD BE THE CAUSE OF THE GUIDEWIRES MISSING THE NAIL'S RECON HOLES. A FEW MILLIMETERS OF TOGGLE COULD CREATE A MISPLACED GUIDE WIRE THE SALES REP COMMENTED THAT THE INSTRUMENTS HAVE GOTTEN LOOSE OVER THE YEARS AS THEY HAVE BEEN USED. THERE WAS A SURGICAL DELAY OF 5-8 MINUTES. THE SURGERY WAS COMPLETED USING THE SAME AIMING ARMS AND THE STANDARD LOCKING OPTION FOR THE PATIENT. IT WAS AN IMPENDING FRACTURE DISTALLY DOWN THE SHAFT OF THE FEMUR, SO NOTHING WAS COMPROMISED. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN RECON NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COM

  Patient problems: No Code Available

  MAUDE report 8945846 ↗
• InjuryAug 29, 2019Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  UPDATED EVENT DESCRIPTION (ADDITIONAL INFORMATION) IT WAS REPORTED THAT DURING A RECON NAIL SURGERY ON (B)(6) 2019, THE CANNULAS OF TWO (2) RADIOLUCENT RECON AIMING ARM FOR EXPERT LATERAL FEMORAL NAIL (LFN) WERE A LITTLE BIT LOOSE INSIDE. THE GUIDE WIRES FOUR (4) WAS MISSING THE RECON NAIL HOLE POSTERIOR AND ANTERIOR BY QUITE A BIT AND WAS UNABLE TO PROCEED WITH THE RECON NAIL LOCKING OPTION BECAUSE OF IT. EVEN AFTER LOCKING THE LARGEST GOLD CANNULA INTO THE RADIOLUCENT AIMING ARM, THE SURGEON AND THE SALES REP FELT AS THOUGH THERE WAS SOME "WIGGLE" ROOM OR A LITTLE BIT OF TOGGLE THAT COULD BE THE CAUSE OF THE GUIDEWIRES MISSING THE NAIL'S RECON HOLES. A FEW MILLIMETERS OF TOGGLE COULD CREATE A MISPLACED GUIDE WIRE THE SALES REP COMMENTED THAT THE INSTRUMENTS HAVE GOTTEN LOOSE OVER THE YEARS AS THEY HAVE BEEN USED. THERE WAS A SURGICAL DELAY OF 5-8 MINUTES. THE SURGERY WAS COMPLETED USING THE SAME AIMING ARMS AND THE STANDARD LOCKING OPTION FOR THE PATIENT. IT WAS AN IMPENDING FRACTURE DISTALLY DOWN THE SHAFT OF THE FEMUR, SO NOTHING WAS COMPROMISED. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN RECON NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COM

  Patient problems: No Code Available

  MAUDE report 8945814 ↗
• MalfunctionMay 5, 2017Failure to Align; Failure to Align

  ON 18JUN2017 UPDATE: A CANNULATED CONNECTION SCREW (PART NUMBER 03.010.146 AND LOT NUMBER U109603) WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6548750 ↗
• InjuryJan 5, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING AN INITIAL LEFT FEMORAL SHAFT FRACTURE SURGERY ON (B)(6) 2016, THE RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN WOULD NOT LINE UP. WHILE THE SURGEON WAS INSERTING THE NAIL, HE HAD TO POUND IT DOWN AS IT FELT TIGHT. THE NAIL WAS LOCKED DISTALLY. WHEN HE WAS READY TO PERFORM THE PROXIMAL LOCKING, THE AIMING ARM WOULD NOT LINE UP. HE COULDN¿T GET THE DRILL BIT IN. HE FELT LIKE HE WAS TOUCHING THE NAIL AND THOUGHT THE HOLES WERE OFF. HE MANUALLY ADJUSTED THE AIMING ARM BUT COULD NOT GET IT TO FUNCTION. HE TOOK THE AIMING ARM WITH DRILL GUIDE OFF AND DRILLED THE HOLES FREE-HANDED. HE WAS ABLE TO SUCCESSFULLY IMPLANT THE SCREWS. THIS RESULTED IN APPROXIMATE THIRTY (30) MINUTES SURGICAL DELAY. UNANTICIPATED X-RAYS WERE TAKEN. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS REPORTED AS STABLE. AFTER THE PROCEDURE, THE AIMING ARM AND DRILL GUIDE WERE TESTED WITH A NEWLY OPENED NAIL TO SEE IF THE AIMING ARM WAS BENT. HOWEVER, THE AIMING ARM WORKED FINE. CONCOMITANT DEVICES REPORTED: 10MM TITANIUM LATERAL ENTRY FEMORAL RECON NAIL-EX/340MM/LT-STERILE (PART # 04.003.349S, LOT # 7568164, QUANTITY #), RADIOLUCENT INSERTION HAND

  Patient problems: No Code Available

  MAUDE report 6224721 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040336. 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.