NA 03.168.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982275011), received between May 30, 2018 and Feb 5, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Device Slipped

  IT WAS REPORTED THAT DURING AN FNS CASE, EVEN THOUGH THE NUT WAS TIGHTENED DOWN ON THE DRILL BIT, THE REAMER DID NOT STAY IN PLACE ALONG THE DRILL BIT. WE HAVE CAUGHT SEVERAL THAT WERE VERY LOOSE ON THE ACTUAL DRILL BIT. WE¿VE HAD TO SQUEEZE A COUPLE REAMER HEADS WITH PLIERS TO GET THEM TO HOLD ONTO THE DRILL BIT A LITTLE BIT BETTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268733 ↗
• MalfunctionApr 24, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT DURING A FEMORAL NECK FRACTURE ORIF WHILE USING THE FEMORAL NECK SYSTEM REAMER THE NUT LOOSENED FOR NO APPARENT REASON CAUSING THE 12.5MM REAMER TO SLIDE ON THE 10.2MM CANNULATED DRILL BIT CAUSING IT TO OVER INSERT INTO THE FEMORAL HEAD ALMOST CUTTING THROUGH INTO THE ACETABULUM. THIS COMPLAINT IS RELATED TO (B)(6). THIS COMPLAINT IS CREATED TO CAPTURE THE SAME EVENT OF NUT LOOSENING HAPPENING IN SOME OTHER OCCASION. FOLLOW UP HAS BEEN INITIATED FOR THE DETAIL EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21899441 ↗
• InjuryJul 3, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A FIXATION WITH FNS IMPLANTS. THE PRIMARY SURGEON WAS A FIRST-YEAR SURGEON. DURING SURGERY, THE NUT LOOSENED, AND THE REAMER PERFORATED THE BONE HEAD. DURING REAMING FOR THE BOLT, THE PUSHING FORCE WAS TOO STRONG, RESULTING IN PERFORATION OF THE BONE HEAD. POSSIBLE CAUSES OF THIS EVENT WERE AS FOLLOWS: DURING THE IMAGE INTENSIFIER CHECK, THE REAMER PART WAS HIDDEN BY THE PROTECTION SLEEVE, AND THE SURGEON DID NOT NOTICE THAT THE REAMER PART WAS LOOSE UNTIL LATER. THE SURGEON WAS SO FOCUSED ON CHECKING THE LATERAL SKIN CUT CONTACT AT THE BASE OF THE REAMER THAT THE SURGEON WAS LATE IN NOTICING THE REAMER WAS ADVANCING REAMING. AFTER CONSULTING WITH A SURGEON WHO IS AN EXPERT IN TREATMENT OF LOWER EXTREMITY, IT WAS DETERMINED THAT ALTHOUGH THE BONE HEAD WAS PERFORATED, IT WAS NOT A MAJOR PERFORATION, AND THE SURGERY WAS COMPLETED BY FIXING WITH FNS IMPLANTS AS IT WAS PLANNED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PRIMARY SURGEON COMMENTED THAT THE EVENT WAS CAUSED BY THE SURGEON¿S TECHNICAL ERROR AND THAT A REAMER SHOULD BE CHANGED

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17251112 ↗
• InjuryFeb 16, 2020Device Slipped; Loosening of Implant Not Related to Bone-Ingrowth; Device Slipped; Loosening of Implant Not Related to Bone-Ingrowth

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL NECK FRACTURE (AO CLASSIFICATION 31B1) WITH FNS. THE SURGEON USED PROTECTION SLEEVE (03.023.002) IN REAMING. HOWEVER, THE DRILL BIT PENETRATED THE BONE HEAD BECAUSE THE NUT WAS DETACHED FROM THE REAMER. THE SURGEON CONTINUED THE SURGERY AND INSERTED THE BOLT, ANTIROTATION-SCREW AND THE PLATE WITH LOCKING SCREW. THE SURGERY WAS COMPLETED WITH NO DELAY. THE SURGEON COMMENTED THAT HE OVER-REAMED BECAUSE THE NUT OF THE REAMER HAD BEEN LOOSED AND DETACHED. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: PROTECTION SLEEVE (PART # 03.023.002, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) NUT FOR REAMER. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9715427 ↗
• InjuryJul 29, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE OSTEOSYNTHESIS SURGERY FOR THE FEMORAL NECK FRACTURE (GARDEN II TYPE) WAS PERFORMED WITH FNS. DURING THE SURGERY, THE NUT GOT LOOSENED AND THE REAMER PROTRUDED FROM THE FEMORAL HEAD. THE FNS DEVICES WERE IMPLANTED AS PLANNED. THERE WAS NO SURGICAL DELAY. THE SURGEON WAS WORRIED THE IMPLANT MAY PENETRATE THE FEMORAL HEAD BECAUSE THERE IS NO BONE WHICH SUPPORT THE IMPLANT FROM THE FEMORAL HEAD SIDE. THE SURGEON ALSO COMMENTED THAT THE ROTATION DIRECTION TO LOOSEN THE NUT AND THAT OF THE REAMER SHOULD BE DIFFERENT. THE ALERT DATE IS (B)(6) 2019 (JST). NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN FNS PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN FNS BOLT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN ANTIROTATION SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 8839637 ↗
• MalfunctionJan 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, AN OPEN REDUCTION INTERNAL FIXATION WAS APPLIED DURING A SURGERY FOR A FEMORAL NECK FRACTURE. WHILE THE SURGEON WAS REAMING THE BONEHEAD WITH THE REAMER, HE NOTICED THAT THE NUT HAD COME OFF THE DRILL BIT IN QUESTION. THE SURGEON REMOVED THE REAMER FROM THE BONE; THEN, HE TRIED TO DISASSEMBLE IT. HOWEVER, THE NUT AND THE REAMER PORTION CRACKED, AND HE COULD NOT REMOVE THEM FROM THE DRILL BIT. THE SURGERY WAS COMPLETED WITH A THIRTY (30) MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. AFTER THE SURGERY, IT WAS TRIED AGAIN TO DISASSEMBLE THE REAMER, BUT IT COULD NOT BE DONE MANUALLY. AFTER HAMMERING THE DRILL BIT, DISASSEMBLING THE REAMER WAS SUCCESSFUL. THIS REPORT IS FOR A NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8223348 ↗
• InjuryMay 30, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT OPEN REDUCTION INTERNAL FIXATION (ORIF) WAS APPLIED TO FEMORAL NECK FRACTURES ON (B)(6) 2018. ACCORDING TO THE SURGICAL INSTRUCTIONS, THE SURGEON USED THE REAMER WITH A GUIDE WIRE FOR REAMING THE BONE HEAD. THEN, SHE NOTICED THE DRILL BIT HAD KEPT SPINNING UNEXPECTEDLY, PENETRATED THE BONE HEAD, AND REACHED THE ACETABULAR CARTRIDGE. IT WAS PREOPERATIVELY CONFIRMED BY THE SURGEON AND HOSPITAL STAFF THAT THE STOPPER OF THE REAMER HAD BEEN PROPERLY FIXED. ALSO, THE STAFF IS USED TO HANDLING TRIPLE REAMERS. AFTER THE SURGERY, THE REAMER WAS INSPECTED, AND NO DEFECT WAS NOTICED IN THE STOPPER MECHANISM. ONE CAUSE MIGHT HAVE BEEN ATTRIBUTABLE TO OVERLOADING, IF ANY, AGAINST A REAMER NUT TO BECOME LOOSE. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED DELAY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS FOR A NUT FOR REAMER COMPONENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 7552926 ↗