NA 309.530Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10886982185846), received between Feb 23, 2017 and Apr 21, 2026 — classified as 12 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Break” (45 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT REMOVAL SURGERY WITH THE DEVICE IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THIRTY MINUTES SURGICAL DELAY. AFTER THE SURGERY, ON (B)(6) 2026, THE SALES REPRESENTATIVE WAS INFORMED THAT THE DEVICE WAS DAMAGED DURING THE OPERATION. THE OPERATION WAS COMPLETED SAFELY USING ANOTHER DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24940605 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY AFTER THE SURGERY, OSTEONECROSIS OF THE FEMORAL HEAD OCCURRED, AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. CONSIDERING THE RISK OF TROUBLE WITH THE LATERAL SCREW REMOVAL, THE SURGEON TRIED TO REMOVE IT WITH THE INSERTION HANDLE ATTACHED TO THE PLATE FROM THE BEGINNING, BUT THE LATERAL SCREW COULD NOT BE REMOVED, AND THE TIP OF THE SCREWDRIVER FOR REMOVAL T25 FNS (POLO PRODUCT) TWISTED AND BROKE. AFTER RETRIEVING THE BROKEN SCREWDRIVER TIP, THE SCREWHEAD THREADS WERE NOT COMPLETELY CRUSHED AND THE SCREWDRIVER TIP WAS ABLE TO FIT, SO THE SURGEON NEXT REMOVED THE INSERTION HANDLE AND USED THE SCREWDRIVER STAR DRIVER T25 SHORT SET (UNK SCREWDRIVER) TO REMOVE THE LATERAL SCREW, BUT THE TIP OF THIS SCREWDRIVER ALSO BROKE. AFTER RETRIEVING THE BROKEN SCREW TIP, THE SCREW HEAD WAS STRIPPED, SO THE USED THE EXTRACT-SCREW OF THE LARGE REMOVAL INSTRUMENT, BUT THE TIP OF THIS ALSO BROKE WHEN IT WAS BITTEN INTO THE SCREW. AT THIS POINT, THE SURGEON DECIDED THAT IT WAS IMPOSSIBLE TO REMOVE THE LATERAL SCREW WITH A SCREWDRIVER AND DECIDED TO USE CARBIDE DRILL TO GRIND DOWN THE PLATE. AS THERE WAS ONLY ONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564221 ↗
• MalfunctionJul 2, 2025Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT THE REMOVAL SURGERY FOR FEMORAL FRACTURE. DURING THE LCP-DF REMOVAL SURGERY, EXTRACT-SCREW WAS USED BECAUSE IT WAS DIFFICULT TO REMOVE THE LOCKING SCREW. HOWEVER, EVEN THE EXTRACT-SCREW COULD NOT REMOVE THE LOCKING SCREW AND IT BROKE. TWO EXTRACT SCREWS WERE BROKEN. ALTHOUGH THE BROKEN FRAGMENTS REMAINED IN THE SCREW HEAD, THE SURGEON GAVE UP ON REMOVAL AND CLOSED THE WOUND. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22383405 ↗
• MalfunctionJul 2, 2025Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT THE REMOVAL SURGERY FOR FEMORAL FRACTURE. DURING THE LCP-DF REMOVAL SURGERY, EXTRACT-SCREW WAS USED BECAUSE IT WAS DIFFICULT TO REMOVE THE LOCKING SCREW. HOWEVER, EVEN THE EXTRACT-SCREW COULD NOT REMOVE THE LOCKING SCREW AND IT BROKE. TWO EXTRACT SCREWS WERE BROKEN. ALTHOUGH THE BROKEN FRAGMENTS REMAINED IN THE SCREW HEAD, THE SURGEON GAVE UP ON REMOVAL AND CLOSED THE WOUND. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22383402 ↗
• MalfunctionJun 13, 2025Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A REMOVAL SURGERY DISTAL FEMUR FRACTURE WITH THE EXTRACT SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. HE EXTRACT-SCREW BROKE AND REMAINED INSIDE THE LOCKING HEAD. THEREFORE, THE SURGEON ATTEMPTED TO SEPARATE THE PLATE FROM SCREW WITH THE CARBIDE DRILL, BUT THE EXTRACT-SCREW WAS SO HARD THAT IT COULD NOT BE CUT AWAY AT ALL. THE SURGEON GAVE UP ON REMOVAL AND COMPLETED THE SURGERY LEAVING ONE PLATE AND SCREW IN PLACE. THE SURGEON MENTIONED THAT THE BROKEN PART OF THE EXTRACT-SCREW REMAINED IN THE SCREW HEAD, MAKING IT IMPOSSIBLE TO CUT IT OUT WITH THE CARBIDE DRILL, AND THAT HE COULD NOT SEPARATE THE PLATE FROM THE SCREW AND HAD TO CHOOSE TO LET IT REMAIN IN THE BODY. THE SURGEON ALSO MENTIONED THAT HE USED A SHORT-HANDLE EXTRACTION DRILL AND ASSUMED THAT THE POSSIBILITY OF BREAKAGE WAS LOW.

  Patient problems: Foreign Body In Patient

  MAUDE report 22205524 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, A REMOVAL SURGERY WAS PERFORMED. ON (B)(6) 2023, A PRIMARY SURGERY WAS PERFORMED WITH THE LCPDF. WHEN THE SURGEON TRIED TO REMOVE THE LOCKING SCREW, THE SCREW HEAD GOT STRIPPED. ALTHOUGH THE EXTRACTION SCREW IN QUESTION WAS USED, THE EXTRACTION SCREW BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SALES REP IS CONFIRMING ABOUT DETAILS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702300 ↗
• MalfunctionFeb 21, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT IS BLUNT AND CHIPPED OFF. THIS WAS 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 ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434935 ↗
• MalfunctionSep 11, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO BROKEN FRAGMENT REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195815 ↗
• MalfunctionJul 17, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BURRED OFF. THIS WAS IDENTIFIED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION ON JUNE 24, 2024. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766503 ↗
• MalfunctionJul 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TIP OF THE INSTRUMENT HAS BEEN DAMAGED OR WORN OFF. THIS WAS IDENTIFIED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730394 ↗
• MalfunctionMay 16, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE SURGERY, THE EXTRACTION SCREW BROKE WHEN REMOVING THE CLOSING CAP FOR THE SCREW 4.5 + 6.5. THIS REPORT INVOLVES ONE (1) CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19336132 ↗
• MalfunctionMay 6, 2024Break; Break

  THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO ACHIEVEMENT OF BONE FUSION. THE CONICAL EXTRACTION SCREW WAS USED DURING THE PROCEDURE. PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255854 ↗
• MalfunctionMar 5, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDONESIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEM BROKE THE FIRST TIME IT WAS USED FOR REMOVE LOCKING SCREW 5.0 HEX WITH DAMAGE RECESS. THIS DID NOT AFFECT THE PATIENT. THIS REPORT IS FOR ONE (1) EXTRACT-SCREW CONI F/SCR Ø4.5+6.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838986 ↗
• MalfunctionFeb 13, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A REMOVAL OF PTP LARGE IMPLANTS. THE LOCKING SCREW IN QUESTION COULD NOT BE REMOVED BY A SCREWDRIVER, AND AN EXTRACTION SCREW WAS USED FOR ITS REMOVAL. NATURALLY, THE SCREW WAS NOT UNLOCKED, AND THE EXTRACTION SCREW BROKE OFF. THE SALES REP DID NOT INFORM THE SURGEON OF THE CORRECT PROCEDURE. AFTER THAT, THE SURGEON REMOVED THE PLATE BY A CARBIDE DRILL. WHEN THE HOLLOW REAMER WAS ATTACHED TO THE POWER TOOL AND ROTATED, ROTATION WAS ECCENTRIC. THE ROTATION WAS ECCENTRIC NO MATTER HOW MANY TIMES THE SURGEON ENGAGED THE HOLLOW REAMER WITH A JACOBS CHUCK. THE SURGEON DID NOT USE THAT HOLLOW REAMER BUT USED A ONE-SIZE LARGER REAMER TO REMOVE THE SCREW, AND THE SCREW WAS REMOVED WITHOUT ANY PROBLEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. PATIENT STATUS/ OUTCOME: STABLE THE SURGEON COMMENTED THAT THE AXIS WASN'T STRAIGHT. ALTHOUGH NOT APPARENT, ROTATING HOLLOW REAMER REVEALED THAT THE AXIS WAS BENT. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXTRACT-SCREW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695711 ↗
• MalfunctionFeb 1, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT WAS BROKE. THERE WAS NO OTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) EXTRACT-SCREW CONI F/SCR Ø4.5+6.5 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624573 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE SURGEON ATTEMPTED TO REMOVE A SCREW ORIGINALLY IMPLANTED 9 YEARS AGO. DURING THE PROCEDURE THE CONICAL EXTRACTION PIECE BROKE INTO THE SCREW HEAD. THE SURGEON LEFT THE SCREW IN THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139332 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121673 ↗
• MalfunctionOct 4, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS IDENTIFIED THAT THE TIPS OF THE INSTRUMENTS HAD BEEN SNAPPED OFF. THIS WAS NOTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869364 ↗
• MalfunctionAug 30, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT PRIMARY SURGERY FOR RIGHT FEMUR SUPRACONDYLAR FRACTURE WITH DF PLATE AT ANOTHER HOSPITAL. ON AN UNKNOWN DATE, NON-UNION OCCURRED. ON (B)(6) 2023, THE PATIENT UNDERWENT REMOVAL SURGERY. WHEN THE SURGEON TRIED TO REMOVE THE LOCKING SCREW OF INTERNALLY FIXED THE DF PLATE, THE TIP OF THE EXTRACTION SCREW GOT STUCK IN THE SCREW HEAD AND BROKE. THE SURGEON INITIALLY ATTEMPTED EXTRACTION WITH A SCREWDRIVER BUT CHANGED TO AN EXTRACTION SCREW BECAUSE THE SCREW HEAD STRIPPED. HOWEVER, THE LOCKING SCREW DID NOT MOVE AT ALL, AND THE TIP OF THE EXTRACTION SCREW BROKE WHILE THE SURGEON CONTINUED TO APPLY COUNTERCLOCKWISE FORCE. THE CORNER OF THE EXTRACTION SCREW BURIED IN THE SCREW HEAD PROTRUDED AND WAS CUT WITH A CARBIDE DRILL. THEN, THE PROTRUDING PART WAS LEVELED SO THAT IT WOULD NOT INTERFERE WITH THE SOFT TISSUE WHEN THE WOUND WAS CLOSED. FINALLY, LEAVING THE DF PLATE AND THE SCREW THAT COULD NOT BE REMOVED IN THE BODY, THE NON-UNION AREA WAS FRESHENED AND REPLACED WITH AUTOGENOUS BONE. A LONG SCREW WAS INSERTED INTO ANOTHER HOLE THAT WAS SUCCESSFULLY REMOVED TO COMPLETE THE

  Patient problems: Insufficient Information

  MAUDE report 17651922 ↗
• MalfunctionJul 24, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A DISTAL FEMORAL FRACTURE ON AN UNKNOWN DATE. ON (B)(6)2023, EXTRACTION SURGERY WAS PERFORMED FOR AN UNKNOWN REASON. DURING THE SURGERY, THE EXTRACTION SCREW WAS BROKEN. A SCREWDRIVER COULD HAVE STRIPPED THE SCREW, SO AN EXTRACTION SCREW WAS USED, WHICH IMMEDIATELY BROKE OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377213 ↗
• MalfunctionJun 13, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT HAS SNAPPED OFF. THE PRODUCT DAMAGE WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17116066 ↗
• 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)(6) 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 16497267 ↗
• MalfunctionFeb 15, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 18, 2023, THE PATIENT UNDERWENT THE PRIMARY SURGERY FOR THE FEMUR. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2023 A REMOVAL SURGERY WAS PERFORMED WITH THE HANDLE AND THE EXTRACTION SCREW, SINCE THE BONE UNION WAS ACHIEVED. DURING THE REMOVAL OF THE DF PLATE, THE HANDLE AND THE EXTRACTION SCREW BROKE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SIXTY(60) MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380290 ↗
• MalfunctionFeb 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE EXTRACTOR SCREW HAS SEIZED ONTO THREADED IMPLANT. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) EXTRACT-SCREW CONI F/SCR Ø4.5+6.5 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373772 ↗
• MalfunctionNov 16, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, THE INSTRUMENTS HAD WORN TIPS AND DID NOT HAVE GOOD GRIPS ON THE SCREWS. THIS INCIDENT HAD PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804148 ↗