NA 309.521Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982185839), received between Jun 29, 2018 and Sep 6, 2024 — classified as 18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A MEDIAN STERNOTOMY CLOSURE SURGERY ON (B)(6) 2024, A CONICAL SCREW BREAKAGE OCCURRED. THE INSTRUMENT SHEARED OFF FLUSH WITH THE SCREW HEAD. SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE EVENT. THE BROKEN PIECE WAS PICKED OUT WITH A DENTAL PICK AND THE SURGERY CARRIED ON WITH ANOTHER CONICAL EXTRACTION BOLT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE FRAGMENTS GENERATED WERE EASILY REMOVED. THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155638 ↗
• MalfunctionJan 25, 2024Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 11 2024, THE PRODUCT DAMAGE DOCUMENTED HAD BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) EXTRACTSCR F/SCR Ø3.5 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580505 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS FURTHER REPORTED THAT THIS WAS A LOAN KIT, AND THERE WAS NO ADVERSE EFFECTS, NO SURGICAL DELAY. THE OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002803 ↗
• MalfunctionJul 11, 2023Break; Break

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE EXTRACTION SCREW BROKE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE; THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17301830 ↗
• MalfunctionDec 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15964490 ↗
• MalfunctionJun 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE EXTRACTOR COULD NOT BE REMOVED FROM THE SCREW. THIS REPORT IS FOR ONE (1) EXTRACTSCR F/SCR Ø3.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654516 ↗
• MalfunctionJun 29, 2021Break; Break

  THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084221 ↗
• MalfunctionMay 24, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A HARDWARE REMOVAL OF AN UNKNOWN PROXIMAL FEMUR PLATING CONSTRUCT, A COUPLE OF UNKNOWN SCREW REMOVAL EXTRACTORS WERE BROKEN AND DAMAGED. ALL BROKEN PIECES WERE SUCCESSFULLY REMOVED. THERE WAS UNKNOWN SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR (1) CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. THIS REPORT IS 2 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869963 ↗
• MalfunctionJan 13, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THAT THE COLONICAL EXTRACTION SCREW BROKE. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11164463 ↗
• MalfunctionDec 26, 2020Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED PIECE OF THE EXTRACTING END OF THE EXTRACTOR HAS BROKEN OFF. THIS WAS DISCOVERED DURING INSPECTION OF THE LOAN KIT. THIS REPORT IS FOR AN EXTRACTOR. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11073923 ↗
• MalfunctionDec 18, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS REPORTED AS BROKEN. THERE WAS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491429 ↗
• MalfunctionMay 29, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT AN OSTEOSYNTHESIS SURGERY WITH THE PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM (PHILOS) DUE TO A FRACTURE. DURING THE IMPLANTATION OF THE PROXIMAL HUMERAL PLATE, IT WAS IMPOSSIBLE TO REMOVE THE PLATE FROM THE INSERTION HANDLE. THE SURGEON REMOVED THE IMPLANTED PLATE DUE TO IT WAS IMPOSSIBLE TO DETACH THE INSERTION HANDLE AND ANOTHER PLATE WAS IMPLANTED BUT NOT MINI-INVASIVE. THERE WAS A SURGICAL DELAY OF AT LEAST 2 HOURS. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. THIS IS REPORT 3 OF 4 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 4 OF 14 DEVICES. PLEASE SEE THE LINKED COMPLAINT (B)(4) FOR THE ADDITIONAL TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8651511 ↗
• MalfunctionMay 29, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT AN OSTEOSYNTHESIS SURGERY WITH THE PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM (PHILOS) DUE TO A FRACTURE. DURING THE IMPLANTATION OF THE PROXIMAL HUMERAL PLATE, IT WAS IMPOSSIBLE TO REMOVE THE PLATE FROM THE INSERTION HANDLE. THE SURGEON REMOVED THE IMPLANTED PLATE DUE TO IT WAS IMPOSSIBLE TO DETACH THE INSERTION HANDLE AND ANOTHER PLATE WAS IMPLANTED BUT NOT MINI-INVASIVE. THERE WAS A SURGICAL DELAY OF AT LEAST 2 HOURS. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 4 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 4 OF 14 DEVICES. PLEASE SEE THE LINKED COMPLAINT (B)(4) FOR THE ADDITIONAL TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8651489 ↗
• MalfunctionMay 29, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT AN OSTEOSYNTHESIS SURGERY WITH THE PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM (PHILOS) DUE TO A FRACTURE. DURING THE IMPLANTATION OF THE PROXIMAL HUMERAL PLATE, IT WAS IMPOSSIBLE TO REMOVE THE PLATE FROM THE INSERTION HANDLE. THE SURGEON REMOVED THE IMPLANTED PLATE DUE TO IT WAS IMPOSSIBLE TO DETACH THE INSERTION HANDLE AND ANOTHER PLATE WAS IMPLANTED BUT NOT MINI-INVASIVE. THERE WAS A SURGICAL DELAY OF AT LEAST 2 HOURS. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. DUE TO SYSTEM LIMITATION, THIS EVENT IS CAPTURED UNDER THIS (B)(4) AND LINKED (B)(4). CONCOMITANT DEVICE: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXTRACTION SCREW. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8650106 ↗
• MalfunctionFeb 4, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS REMOVING A 4.0 CANNULATED SCREW FOR AN UNKNOWN REASON. DURING REMOVAL THE UNKNOWN 4.0 CANNULATED SCREW BROKE. IT WAS REPORTED THAT THE FOLLOWING INSTRUMENTS "BROKE INTRAOPERATIVELY": THE CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS, SPARE REAMER TUBE FOR HOLLOW REAMER, EXTRACTION BOLT FOR 4.5 SCREWS, SPARE REAMER TUBE FOR HOLLOW REAMER, SMALL HANDLE WITH QUICK COUPLING, AND CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. SURGICAL DELAY IS UNKNOWN. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8301642 ↗
• MalfunctionJan 22, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL OF HARDWARE ON THE RIGHT HIP, THE AO COUPLING EXTENSION SHAFT THAT WAS CONNECTED TO A BROKEN CONICAL EXTRACTION SCREW WAS TWISTED AND BENT. EXTENSION PIECE TORQUED AND TWISTED IN DRIVE SHAFT. THE ISSUE HAPPENED WHEN THE SURGEON ENGAGED THE DRILL WHILE ATTEMPTING TO REMOVE A STRIPPED LOCKING SCREW WHICH THE TIP WAS BROKE OFF IN THE BONE. THE BONE WAS HARD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TWO (2) MINUTES OF SURGICAL DELAY REPORTED. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN DRILL BITS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN DRILL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266706 ↗
• MalfunctionJun 29, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING DECONTAMINATION PROCEDURE, FOUR (4) DEVICES WERE DISCOVERED TO BE NOT FUNCTIONING. ON A CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS, THE THREAD WAS DAMAGED. TWO INSTANCES OF CONICAL EXTRACTION SCREWS FOR 3.5MM SCREWS WERE BROKEN. A SPARE REAMER TUBE FOR HOLLOW REAMER WAS ALSO BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7650073 ↗
• MalfunctionJun 29, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING DECONTAMINATION PROCEDURE, FOUR (4) DEVICES WERE DISCOVERED TO BE NOT FUNCTIONING. ON A CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS, THE THREAD WAS DAMAGED. TWO INSTANCES OF CONICAL EXTRACTION SCREWS FOR 3.5MM SCREWS WERE BROKEN. A SPARE REAMER TUBE FOR HOLLOW REAMER WAS ALSO BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7649975 ↗