NA 03.168.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982275004), received between Jul 29, 2019 and Feb 5, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (5 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 11 most recent of 11 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 24268664 ↗
• MalfunctionFeb 10, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. BEFORE THE SURGERY, IT WAS CONFIRMED THAT THE REAMER'S CONVEX PART TO FIT THE REAMER'S NUMBER WAS LOOSE AT THE PRE-STERILIZATION CHECK. IT WAS SO LOOSE THAT IT WAS PUSHED UP WHEN TRYING TO TIGHTEN THE NUT. A DIFFERENT INSTRUMENT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349685 ↗
• MalfunctionFeb 2, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF WITH FNS IMPLANT FOR FEMORAL NECK FRACTURE. THE SURGERY WAS BEING PERFORMED AS NORMAL TECHNIQUE, BUT THE PATIENT SEEMED LIKE PETITE, AND PATIENT¿S MEASUREMENT FIGURE WAS 78MM, SO MINIMUM FIGURE OF 75MM WAS USED FOR BONEHEAD REAMING. TO AVOID PENETRATING TO BONEHEAD, IT WAS JUDGED THAT INSERTING REAMER DIAMETER 12.5MM FNS TO THE PROPER DEPTH SEEMS LIKE DIFFICULT. DUE TO INSUFFICIENT DEPTH, THE PLATE WAS NOT REACHED INTO PROPER DEPTH. AS A RESULT, APPROXIMATE 7MM OF GAP WAS MADE AND THE PLATE WAS FIXED AS SOMEWHAT FLOATING CONDITION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. A SURGEON REQUESTED AN APPROACH FOR PETITE USE SO THE TROUBLE LIKE THIS TIME OCCURRED IN PREVIOUS TIME AS WELL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) REAMER Ø12.5 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629180 ↗
• InjuryJul 6, 2023Device Slipped; Improper or Incorrect Procedure or Method; Device Slipped; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A FIXATION WITH FNS IMPLANTS. 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 A 30-MINUTE DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 12.5MM REAMER COMPONENT OF THE 03.168.004. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17265391 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THIS IS NOT DIRECTLY RELATED TO A PATIENT THIS IS DAMAGED TO A REAMER COMPONENT OF FNS REAMER COMPONENT. THIS COMPONENT HAS SOME PARTS INTO PIECES THAT WILL NOT FUNCTION DURING A CASE THAT NEEDS TO BE REPLACED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 12.5 REAMER COMPONENT OF THE 03.168.004. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245463 ↗
• MalfunctionDec 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  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) 12.5 REAMER COMPONENT OF THE 03.168.004. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052496 ↗
• MalfunctionDec 8, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR FEMORAL NECK FRACTURE WITH FEMORAL NECK SYSTEM (FNS) IMPLANTS. WHEN THE SURGEON WAS REAMING, THE NUT OF THE REAMER GOT LOOSE, AND REAMING WAS PROCEEDED WITH THE STOPPER NOT WORKING. THE SURGEON CONFIRMED THAT THE REAMING DID NOT REACH THE JOINT AND PROCEEDED THE OPERATION. THE SURGERY WAS COMPLETED WITHIN THIRTY (30) MINUTES DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 12.5MM REAMER COMPONENT OF THE 03.168.004. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964386 ↗
• MalfunctionFeb 22, 2021Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE FNS SURGERY FOR THE FEMORAL NECK FRACTURE WITH THE REAMER AND NUT IN QUESTION. BEFORE THE SURGERY, WHEN THE SALES REP SHOWED HOW THE INSTRUMENT IS USED, THE ENGAGEMENT BETWEEN THE REAMER AND NUT WAS BAD AND THE CONNECTION WAS BAD. ONLY 80MM, THE CONNECTION SEEMED TO BE GOOD. DURING THE SURGERY, THE MEASURING VALUE WAS 85MM. THE SURGEON TRIED TO LOOSEN THE CONNECTION BETWEEN THE REAMER AND NUT WITH THE PLIERS OR FORCEPS, BUT HE COULDN¿T BECAUSE IT WAS VERY HARD. HE DRILLED WITH THE REAMER (80MM), AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A FORTY-FIVE (45) MINUTES DELAY. THIS REPORT IS FOR A 12.5MM REAMER COMPONENT OF THE 03.168.004. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362158 ↗
• MalfunctionOct 29, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A FEMORAL NECK SYSTEM CASE ON (B)(6) 2020, WHILE SURGEON WAS ATTEMPTING TO USE THE OPENING DRILL, HE NOTICED SOMETHING WAS NOT RIGHT AS THE OPENING DRILL WOULDN¿T ADVANCE AND NOT SPINNING. THE DRILL IS USED TO CREATE A PATH FOR THE PLATE IN BOLT IN THE NECK AND HEAD OF THE FEMUR. THE PROBLEM WAS WITH THE 12.5MM REAMER AND NIT FOR THE REAMER THREADING TOGETHER OVER THE DRILL. AFTER LOOKING AT IT, IT WAS NOTICED THAT THE NUT WAS LOOSE. ATTEMPTED TO TIGHTEN THE NUT, BUT IT WAS NOT WORKING. THE SURGEON ENDED UP CRANKING IN ON IT TO MAKE IT TIGHT. AFTER THE CASE, THE SCRUB TECH WAS TRYING TO UNSCREW THE NUT, BUT IT WAS STUCK. THE REPORTED DEVICES WERE ABLE TO BE SEPARATED WITH THE USE OF GLOVES AND PLIERS. THE THREADS OF THE NUT LOOKED MANGLED, AS IF THEY WERE CROSS THREADED AT ONE POINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 5 MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: 10.2MM CANNULATED DRILL BIT (PART # 03.168.005, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR (1) 12.5MM REAMER COMPONENT OF THE 03.168.004. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10759129 ↗
• 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) 12.5MM REAMER COMPONENT OF THE 03.168.004. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9715429 ↗
• 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 3 OF 3 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 8839639 ↗