NA 03.168.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982274991), received between Jul 29, 2019 and Feb 9, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY WITH FNS FOR TREATMENT ON THE FEMORAL NECK. BEFORE SURGERY, THE SURGEON DISCOVERED THAT BONE FRAGMENTS WERE STUCK TO THE DRILL BIT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE DRILL BIT HAD BEEN USED AT ANOTHER FACILITY, AND THE DISTRIBUTOR WAS NOT ABLE TO CONDUCT SUFFICIENT INSPECTION DUE TO TIME CONSTRAINTS BEFORE DELIVERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299135 ↗
• MalfunctionFeb 5, 2026Device-Device Incompatibility

  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 24268532 ↗
• MalfunctionJul 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 THE DEVICES ARE STUCK TOGETHER. THERE WAS NO OPERATION INVOLVED AND NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22486802 ↗
• MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A FEMORAL NECK FRACTURE ORIF PROCEDURE, 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 AND ALMOST CUTTING THROUGH INTO THE ACETABULUM. THERE WAS A SURGICAL DELAY OF 15 MINUTES. THE REAMER HEAD WAS RE-ADJUSTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21875121 ↗
• MalfunctionAug 7, 2023Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE DRILL BIT FLUTE CHIPPED OFF. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) 10.2MM CANNULATED DRILL BIT LENGTH 251MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17471507 ↗
• MalfunctionFeb 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF FOR FEMORAL NECK FRACTURE WITH THE REAMER IN QUESTION. AS THE SURGEON WAS REAMING TO THE HEAD OF THE BONE WITH THE FNS REAMER THROUGH THE PROTECTION SLEEVE, HE ASKED TWICE FOR THE APPROXIMATE DEPTH OF REAMING. HE WAS TOLD HIM "UNTIL THE REAMER STOPS AT THE LATERAL CORTICAL BONE," AS PER THE PROCEDURE MANUAL BOTH TIMES. HOWEVER, AS THE PROCEDURE PROCEEDED, ONLY THE DRILL HAD ADVANCED ABOUT 1 CM BEYOND THE SUBCHONDRAL BONE OF THE HEAD OF THE BONE. ONCE THE REAMING WAS STOPPED, THE NURSE CHECKED THE REAMER AND FOUND THAT THE NUT HAD BEEN COMPLETELY REMOVED AND THE REAMER SECTION HAD SHIFTED FORWARD. THE SURGEON TOOK OUT THE REAMER AND THE PROTECTION SLEEVES, REASSEMBLED THE REAMER, AND REAMED IT OVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. SINCE THE REAMER¿S SCALE POSITION AND NUT TIGHTNESS WERE CHECKED BEFORE THE SURGERY, THE NUT MAY HAVE BE LOOSENED DUE TO STRONG INTERFERENCE WITH THE PROTECTION SLEEVE. THE SURGEON COMMENTED THAT HE WOULD LIKE TO KNOW HOW OFTEN SIMILAR EVENTS OCCUR AND WHAT THE COMPANY IS DOING ABOUT IT. NO FURTHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280453 ↗
• MalfunctionDec 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT FOR A PROCEDURE. IT WAS NOTED THAT INVOLVED PRODUCT THE FNS FEMORAL NECK SYSTEM, WHERE THE NECK TUBING ZIMMER ASSEMBLY CAME UNDONE WHEN DURING THE ENTIRELY NECK ASSEMBLY NONFUNCTIONAL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 10.2MM CANNULATED DRILL BIT LENGTH 251MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052510 ↗
• InjuryFeb 16, 2020Component or Accessory Incompatibility; Device-Device Incompatibility; Component or Accessory Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) 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, ANTI-ROTATION-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) DRILL BIT Ø10.2 CANN L251. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9715428 ↗
• MalfunctionNov 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL NECK FRACTURE WITH THE REAMER. DURING THE SURGERY, THE SURGEON COULD NOT TURN THE NUT COMPLETELY. THE NUT STOPPED HALFWAY, AND THE SURGEON HAD DIFFICULT IN LOOSENING THE NUT. IT WAS POSSIBLE THAT THE REAMER DIDN¿T FIT IN THE CHASE OF THE DRILL BIT, THE SURGEON MOVED THE REAMER TO FIT THE CHASE. THE SURGEON TRIED TO TURN THE NUT, BUT THE NUT STOPPED HALFWAY, TOO. THE SURGEON LOOSENED THE NUT AGAIN, AND ASSEMBLE THE DEVICES CHECKING THE THREAD OF THE REAMER AND THE NUT, BUT IT WAS NOT WORKED ACCORDINGLY. THE SURGEON USED ANOTHER REAMER, COMPLETE INSTEAD, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT HE COULD NOT FOUND THE DEFECT OF THE DEVICES VISUALLY, BUT HE THOUGHT THAT THERE MIGHT BE THE DEFECT IN THE THREAD OF THE REAMER OR NUT. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9316040 ↗
• 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 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 2 OF 3 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 8839636 ↗