NA 309.065Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982185570), received between Aug 28, 2017 and Dec 30, 2025 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (12 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.

• MalfunctionDec 30, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE BROKEN ROD IS NOT A SYNTHES PRODUCT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23926373 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE SURGERY, THE SURGEON USED THE HOLLOW REAMER FOR REMOVING A SCREW. WHILE THE SURGEON REMOVING THE SCREW, A PART OF THE HOLLOW REAMER BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378060 ↗
• MalfunctionMar 7, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REMOVAL SURGERY FOR WITH THE PRODUCTS IN QUESTION BECAUSE TWO YEARS AFTER THE INITIAL SURGERY ON (B)(4) 2020, SHE SUFFERED OSTEONECROSIS AND NEEDED TO BE REPLACED WITH A THA AFTER FNS REMOVAL. IN THE EXTRACTION OF THE DISTAL 5.0 LOCKING SCREW, THE SCREW DID NOT LOOSEN AT ALL EVEN AFTER CLEANING THE INSIDE OF THE HEAD AND ATTEMPTING EXTRACTION WITH LIGHT HAMMERING OF FNS-3 AND FNS-4. THE INSERTION HANDLE WAS THEN ATTACHED TO THE PLATE AND A SIMILAR EXTRACTION ATTEMPT WAS MADE, BUT THE SCREW DID NOT LOOSEN. THE SURGEON DETERMINED THAT THE SCREW HEAD HAS BEEN STRIPPED AS THE SCREWDRIVER AND SCREW HEAD BITE HAS WEAKENED, AND MOVED TO THE EXTRACTION DRILL AND ATTEMPTED FURTHER EXTRACTION WITH THE EXTRACTION SCREW. THE EXTRACTION SCREW BIT INTO THE SCREW HEAD, BUT THE SCREW DID NOT LOOSEN, RESULTING IN BREAKAGE OF THE EXTRACTION SCREW TIP IN QUESTION. THE SCREW HEADS WERE GROUND OUT WITH A 4.0 CARBIDE DRILL AND A 6.0 CARBIDE DRILL, AND THE ANTI-ROTATION SCREW, NECK BOLT, AND PLATE WERE EXTRACTED. THE SURGEON CONTINUED FURTHER REMOVAL OF THE SCREWS REMAINING IN TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497254 ↗
• MalfunctionFeb 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DEVICE WAS BROKE AND IT IS UNREPAIRABLE LETTER. THIS REPORT IS FOR ONE (1) HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421220 ↗
• MalfunctionJan 12, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW PART OF THE REAMER IN QUESTION WOULD NOT MOVE. THERE IS NO REPORTED PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16147765 ↗
• MalfunctionOct 19, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DEVICE WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633886 ↗
• MalfunctionMay 19, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, DURING A MATERIAL EXTRACTION SURGERY, SEVERAL PIECES OF THE EXTRACTION SET WERE DAMAGED DURING THE TRANSOPERATIVE PERIOD. TWO PIECES OF REVERSE THREADS WERE BROKEN ON THE EXTRACTION SCREWS. A T-HANDLE WAS BENT. IN ADDITION, A TREPHINE WAS BROKEN TRYING TO DRILL BONE TO REMOVE THE SCREW. IT SHOULD BE NOTED THAT NONE OF THE PIECES THAT BROKE REMAINED INSIDE THE PATIENT AND THE SCREWS COULD BE REMOVED AFTER MUCH EFFORT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIXTY (60) MINUTE DELAY AND NO CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR A REAMER TUBE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14433903 ↗
• MalfunctionJan 4, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE STERILE PROCESSING TECHNICIANS HAD ATTEMPTED TO DISASSEMBLE A SCREW REMOVAL INSTRUMENT BUT WERE UNSUCCESSFUL AND BROKE THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13156200 ↗
• InjuryJul 15, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL SURGERY OF A FEMORAL NECK SYSTEM (FNS) NAIL AND TOTAL HIP ARTHROPLASTY. WHEN THE SURGEON TRIED TO REMOVE A SCREW WITH THE SCREWDRIVER WHICH IS OTHER COMPANY¿S PRODUCT, THE SCREWDRIVER BROKE, AND THE TIP OF THE SCREWDRIVER REMAINED IN THE SCREW HEAD. THE SURGEON CUT THE SCREW HEAD WITH A CARBIDE DRILL AND USED THE HOLLOW REAMERS TO REMOVE THE SHAFT OF THE SCREW. THE TIP OF BOTH HOLLOW REAMERS CHIPPED OFF WHEN THE SURGEON WAS REAMING THE BONE. AFTER EXCAVATING THE BONE WITH THE CHIPPED HOLLOW REAMER, THE SCREW WAS REMOVED BY GRASPING WITH PLIERS, AND A TOTAL HIP ARTHROPLASTY WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 45 MINUTE DELAY. THE ADVERSE HEALTH EFFECTS CAUSED BY THIS EVENT WERE AS FOLLOWS: INCREASE IN THE AMOUNT OF BLEEDING ASSOCIATED WITH PROLONGED OPERATION TIME, PROLONGATION OF ANESTHESIA TIME, EXCESSIVE BONE EXCAVATION ASSOCIATED WITH SCREW REMOVAL, AND ADDITIONAL USE OF PHYSIOLOGICAL SALINE FOR REMOVAL OF IRON POWDER ASSOCIATED WITH EXCAVATION. CONCOMITANT DEVICE: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT I

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12174939 ↗
• InjuryMay 20, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT THE SURGERY WITH THE FEMORAL NECK SYSTEM (FNS). AFTER THE SURGERY, ON UNKNOWN DATE, FEMORAL HEAD NECROSIS OCCURRED. ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE FNS IMPLANTS TO REPLACE THEM WITH AN ARTIFICIAL HEAD. WHEN THE SURGEON TRIED TO REMOVE THE LOCKING SCREW, THE TIP OF THE SCREWDRIVER (OTHER COMPANY¿S PRODUCT) GOT TWISTED AND CUT OFF AND STUCK INTO THE LOCKING SCREW¿S HEAD. THE SURGEON CUT THE LOCKING SCREW¿S HEAD WITH A CARBIDE DRILL AND REMOVED THE ANTIROTATION-SCREW, PLATE, AND BOLT. AFTER THAT, WHEN THE SURGEON WAS EXCAVATING THE ANTERIOR CORTICAL BONE WITH THE HOLLOW REAMER, THE TIP OF THE HOLLOW REAMER WAS DAMAGED BECAUSE THE PATIENT¿S BONE WAS HARD. THE SURGEON HOLLOWED CORTICAL BONE OUT WITH A BONE CHISEL AND REMOVED THE SHAFT OF THE LOCKING SCREW EVENTUALLY. THE SCHEDULED REMOVAL TIME WAS 30 MINUTES, BUT THE REMOVAL WAS COMPLETED IN 1 HOUR AND A HALF. DUE TO THE HOLLOW REAMER BREAKAGE, TRACE AMOUNTS OF IRON DEBRIS REMAINED IN THE BODY. THE PATIENT WAS YOUNG AND HAD A VERY GOOD PHYSICAL CONSTITUTION AND BONE QUALITY, IT IS CONSI

  Patient problems: Foreign Body In Patient

  MAUDE report 11858636 ↗
• MalfunctionMar 14, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY OF THE T4-PELVIS DUE TO TWO (2) BROKEN TITANIUM RODS AT L1 AND TWO (2) BROKEN UNKNOWN PEDICLE SCREWS. PATIENT INITIALLY HAD A POSTERIOR SPINAL FUSION TO TREAT A SPINAL DEFORMITY FOR T4-PELVIS ON (B)(6) 2016. DURING REVISION, THE SURGEON USED AN AO BROKEN SCREW REMOVAL SET AND, WHEN USING THE HOLLOW REAMER TO TRY AND EXTRACT THE SCREW, THE HOLLOW REAMER SHAFT BROKE. ALL PARTS OF THE HOLLOW REAMER WERE REMOVED. THE 6MM AND 7MM BROKEN SCREWS AND RODS ON BOTH SIDES WERE SUCCESSFULLY REMOVED USING AN UNKNOWN EXTRACTION BOLT. NEW SCREWS AND COBALT-CHROMIUM RODS WERE IMPLANTED. ADDITIONALLY, TWO (2) UNKNOWN EXPEDIUM SFX CROSS CONNECTORS WERE ALSO USED. THERE WAS A VERY MINIMAL DELAY TO THE SURGERY REPORTED. THE SURGERY WAS COMPLETED WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: PEDICLE SCREWS (PART# 1797.12.745 , LOT# UNKNOWN, QUANTITY# 2), COBALT-CHROMIUM ROD (PART# 1967.91.455, LOT# UNKNOWN, QUANTITY# 1), TITANIUM ROD ROD (PART# 1967.91.455, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) HOLLOW REAMER COMPLETE FOR 6.5

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420391 ↗
• MalfunctionOct 11, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AFTER A DEMO IT WAS IDENTIFIED THAT THE PART OF THE HOLLOW-REAMER WAS BROKEN. THEY ASSUME THIS HAPPENED DURING TRANSPORT. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6942383 ↗
• MalfunctionAug 28, 2017Break; Break

  IT WAS REPORTED THAT THE SPARE REAMER TUBE AND HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0 MM SCREWS WERE DISCOVERED BROKEN DURING ROUTINE MAINTENANCE INSPECTION IN THE STERILE PROCESSING DEPARTMENT. THIS WAS DISCOVERED AFTER STERILE PROCESSING. THIS COMPLAINT DOES NOT INVOLVE ANY PATIENT OR PROCEDURE. PRELIMINARY REVIEW OF THE RETURNED DEVICES REVEALED THE SPARE REAMER TUBE HAS TWO (2) CRACKS ON THE DISTAL END BUT IS NOT BROKEN. THIS REPORT IS FOR ONE (1) HOLLOW REAMER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6825785 ↗