NA 03.010.048Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982067203), received between May 3, 2017 and Feb 12, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (6 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON 29-JANUARY-2024, ONE POST ON THE RECON LOCKING AIMING ARM IS BENT. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684617 ↗
• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF THE BACK UP DEVICES IT WAS DISCOVERED THAT THE GOLD PEG OF ONE (1) RECON LOCKING AIMING ARM FOR LFN NAILS-EX HAS SNAPPED OFF, THE THREADS OF ONE (1) EXTRACTION SCREW FOR TI FEMORAL & TIBIAL NAILS AND ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR ARE STRIPPED, AND ONE (1) DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS WAS STUCK IN PLACE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14001607 ↗
• MalfunctionNov 4, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOSPITAL NOTIFIED THAT THEY HAVE COUPLE OF INSTRUMENTS OF THEIR LATERAL FEMORAL TRAYS AND DHS TRAYS HAVE BROKEN DUE TO WEAR AND TEAR. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE AND PATIENT INVOLVED. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX . THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751144 ↗
• MalfunctionOct 16, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RECON LOCKING AIMING ARM FOR GOLD BARS IS MISSING CAUSING THE SLEEVE TO NOT LOCK IN PLACE. THE ISSUE WAS OBSERVED DURING CLEANING APPROXIMATELY TWO WEEKS AGO. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9198180 ↗
• MalfunctionJun 4, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FEMORAL SHAFT FRACTURE FIXATION. DURING THE PROCEDURE, THE CORRECTLY ASSEMBLED RECON LOCKING AIMING ARM MISSED THE HOLE OF THE NAIL. THE ISSUE WAS RESOLVED INTRA-OPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN (10) MINUTE SURGICAL DELAY. PATIENT STATUS OUTCOME WAS SUCCESSFUL. CONCOMITANT DEVICES: NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), DRILL BIT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A RECON LOCKING AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8668342 ↗
• MalfunctionOct 3, 2018Device-Device Incompatibility; Device-Device Incompatibility

  (B)(6) REPORTS FOLLOWING: IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, THE RECON LOCKING AIMING ARM, PROTECTION SLEEVE, REAMER FOR HIP SCREWS (LATERAL FEMORAL NAIL) LFN AND INSERTION HANDLE FOR EXPERT TIBIAL NAIL AND FEMORAL NAIL (TN+FN) DID NOT ALIGN PROPERLY DUE TO WEAR AND TEAR OVER TIME. THE LOCKING OF THE LFN NAIL WAS BECOMING IMPOSSIBLE WITH THE DESIGNED TARGETING DEVICE. THE TARGETING DEVICE WAS AIMING AT THE LFN NAIL INSTEAD OF AT THE HOLE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE: LFN NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) AIMING ARM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930799 ↗
• MalfunctionAug 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  (B)(6) REPORTED FOLLOWING: IT WAS REPORTED ON THE UNKNOWN PROCEDURE ON (B)(6) 2018, THAT THE RECON LOCKING AIMING ARM DID NOT ALIGN AS IT SHOULD AND DID NOT GIVE THE RIGHT MEASURE. PRODUCE WAS COMPLETED USING ANOTHER DEVICE. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7803022 ↗
• MalfunctionFeb 23, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A PROCEDURE FOR IMPLANTING A SYNTHES LATERAL ENTRY RECON NAIL ON (B)(6) 2018, A 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM WOULD NOT PASS THROUGH THE PROTECTION SLEEVES AND THE NAIL AS IT SHOULD. DURING THIS PROCESS, THE DRILL BIT BROKE INSIDE OF THE PATIENT BONE. THE BROKEN FRAGMENT OF THE DRILL BIT WAS RETRIEVED AND NOTHING WAS LEFT IN THE PATIENT. ALSO, A RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX WAS NOT WORKING PROPERLY AS IT WAS MISALIGNED WITH NAIL, BUT PRIOR TO INSERTION OF FEMORAL NECK/HEAD COMPONENT, NAIL CONNECTION WAS CHECKED AND THE AIMING ARM CONNECTION WAS SECURED AS WELL. TWO OF THE 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING AND TWO 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING WERE ALSO NOT GUIDING THE DRILL BIT PROPERLY THROUGH THE NAIL. A STANDARD INSERTION HANDLE CONNECTED WITH THE AIMING ARM WASN'T WORKING PROPERLY AS THE SALES CONSULTANT HEARD SOME NOISE WHEN THE HANDLE WAS BEING USED. A CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE WAS NOT GETTING CONNECTED PROPERLY AND A 5.0MM FLEXIBLE SHAFT WAS NOT ABLE TO PASS OVER A 2.5MM REAMING ROD. THERE WAS A SURGICAL DELAY OF 30 MINUTES AND THE SURGEON WAS U

  Patient problems: No Code Available

  MAUDE report 7293295 ↗
• MalfunctionNov 15, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT MULTIPLE INSTRUMENTS MALFUNCTIONED DURING A LATERAL ENTRY FEMORAL NAILING TO REPAIR A MIDSHAFT FEMUR FRACTURE DUE TO A MOTOR VEHICLE ACCIDENT ON (B)(6) 2017. AFTER THE SURGEON INSERTED THE NAIL, HE INSERTED THE THREE-PART TROCAR ASSEMBLY, HE THEN CHECKED TO MAKE SURE IT WAS BEING TARGETED CORRECTLY. WHEN HE WENT TO INSERT THE GUIDE WIRE, IT KEPT HITTING THE NAIL AND WAS MISALIGNED. THE MISALIGNMENT ISSUE ONLY HAPPENED WITH ONE GUIDE WIRE AND FIRST SET OF THE THREE-PART TROCAR ASSEMBLY. LATER IN THE PROCEDURE, HE ATTEMPTED TO TAKE THE NAIL OUT, BUT THE HAMMER KEPT GETTING JAMMED AND WOULDN¿T ROCK BACK AND FORTH ON THE HAMMER GUIDE, HE STRUGGLED TO GET THE NAIL OUT. THEN, AS THE DEPTH GAUGE WAS BEING USED TO MEASURE THE LENGTH OF THE RECON SCREWS; THE SURGEON TRIED THREE TIMES AND THE MEASUREMENT WAS INACCURATE, IT WAS 10MM LONGER THAN NEEDED. THERE WAS A REPORTED SURGICAL DELAY OF 10 MINUTES TO TAKE THE NAIL OUT AND REPOSITION IT. NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT INVOLVES NINE (5) DEVICES. CONCOMITANT DEVICES REPORTED: HAMMER GUIDE (PART# UNK

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7035620 ↗
• MalfunctionAug 21, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT AN AIMING ARM WOULD NOT LINE UP PROPERLY WITH A NAIL AND A DEPTH GAUGE WASN¿T SLIDING CORRECTLY DURING A RIGHT LATERAL ENTRY FEMORAL NAILING AND LEFT DISTAL RADIUS OPEN REDUCTION INTERNAL FIXATION (ORIF) ON (B)(6) 2017. AS THE SURGEON WAS TRYING TO DRILL ONE OF THE PROXIMAL HOLES, THE GUIDE (AIMING ARM) ON THE SIDE OF INSERTION HANDLE WAS NOT LINING UP PROPERLY. THE SURGEON LOOSENED IT AND ANGLED IT UNTIL IT WENT THROUGH THE NAIL. THERE WAS NO REPORTED SURGICAL DELAY. ALSO, DURING A LEFT DISTAL RADIUS ORIF DURING THE SAME PROCEDURE, A DEPTH GAGE WASN¿T SLIDING CORRECTLY; THE SLEEVE SEEMED LOOSE. THERE WAS A ONE MINUTE DELAY DEPTH TO OPEN ANOTHER SET TO RETRIEVE ANOTHER GAUGE. THE PATIENT¿S FINAL CONSTRUCTS INCLUDED: ONE FEMORAL NAIL, THREE (3) 5.0MM LOCKING SCREWS, ONE (1) DISTAL RADIUS PLATE AND EIGHT (8) SCREWS, A MIX OF THREE (3) 2.4 CORTEX AND FIVE (5) 2.4 VARIABLE ANGLE (VA) LOCKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: STRYKER POWER DRILL (PART/LOT UNKNOWN, QUANTITY 1), DRILL BIT (PART 03.0101.061, LOT UNKNOWN, QUANTITY 1); FEMORAL NAIL (PART 04.003.356S, LOT H210410, QUANTITY 1); DIS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6807260 ↗
• MalfunctionMay 18, 2017Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A LATERAL FEMORAL NAIL (LFN) PROCEDURE ON (B)(6) 2017, AFFECTED SIDE UNKNOWN AND WAS IMPLANTED WITH AN LFN NAIL AND TWO, 6.5MM RECON SCREWS. AS THE SURGEON WENT TO DRILL FOR THE 6.5MM RECON SCREW, IT WAS REPORTED THAT THE DRILL BIT WAS NOT ALIGNED WITH THE PROXIMAL LOCKING HOLE AND THE DRILL BIT BANGED AGAINST THE NAIL. THE SURGEON REPORTED THAT HE FELT THE STEPPED DRILL BIT WAS GOING TOO FAR ANTERIORLY. IT WAS FURTHER REPORTED THAT THE SURGEON FELT THE INSTRUMENTATION HAD A LOOSE CONNECTION BETWEEN THE INSERTION HANDLE, CONNECTION SCREW AND AIMING ARM. THE SURGEON HAD ATTEMPTED TO REMOVE THE FIRST SCREW FOR REPOSITIONING BUT WAS UNABLE TO REMOVE IT. AS A RESULT, THE SURGEON HAD TO INSERT THE RECON SCREWS WITH SLIGHT HAMMER BLOWS TO GET THEM INTO THE FEMORAL HEAD. THERE WAS A REPORTED DELAY OF 60 MINUTES DUE TO THE ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY AND IT WAS REPORTED THAT THE SURGEON WAS SATISFIED WITH THE FINAL CONSTRUCT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. CONCOMITANT MEDICAL PRODUCTS: STEPPED DRILL BIT (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1),

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6574921 ↗
• MalfunctionMay 4, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE THREE-PART TROCAR COMBINATION WHICH CONSISTED OF THE PROTECTION SLEEVES, WIRE GUIDES, AND TROCARS WAS NOT LINING UP APPROPRIATELY WITH THE HOLES IN THE TITANIUM (TI) LATERAL ENTRY FEMORAL RECON NAIL-EXPERT. PATIENT UNDERWENT A LATERAL ENTRY FEMORAL NAIL PROCEDURE FOR A LEFT FEMUR FRACTURE ON (B)(6) 2017. SURGEON REPORTED THAT HE WAS UNABLE TO ACCURATELY DRILL THE HOLES FOR THE TWO TI RECON SCREWS. IN ADDITION, SURGEON STATED THAT THE AIMING APPARATUS WHICH CONSISTED OF THE AIMING ARM AND INSERTION HANDLE WAS FLIMSY. SURGEON WAS ABLE TO MANIPULATE THE APPARATUS USING HIS HANDS TO GET THE TROCAR COMBINATION TO LINE UP APPROPRIATELY AND IMPLANT THE RECON SCREWS. ADDITIONAL X-RAYS WERE TAKEN TO GET A BETTER VIEW OF THE ISSUE. X-RAYS ARE NOT AVAILABLE FOR REVIEW. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT REQUIRING OTHER MEDICAL INTERVENTION. THERE WAS AN APPROXIMATELY 30 SECONDS TO ONE MINUTE SURGICAL DELAY DUE TO IDENTIFYING THE ISSUE, MULTIPLE FAILED ATTEMPTS, AND HAND MANIPULATION. PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: TI LATERAL ENTRY FEMORAL NAIL (PART 04.003.275S, LOT H210044, QUANTITY 1); TI RECON SCREW (PART 04.0

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6546390 ↗
• MalfunctionMay 3, 2017Failure to Align; Failure to Align

  CONCOMITANT DEVICE REPORTED: TI LATERAL ENTRY FEMORAL NAIL (PART # UNKNOWN, LOT # UNKNOWN, QTY. 1).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6542039 ↗