NA 387.34Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034771083), received between Jan 20, 2017 and May 1, 2024 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT INTRA-OPERATIVELY THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE BROKE PIECE WAS LEFT INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH NO DELAYS. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 19221453 ↗
• MalfunctionFeb 28, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, IT WAS NOTICED BY THE LOAN KIT TECHNICIAN THAT THE TIP OF THE INSTRUMENT HAS SNAPPED OFF. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) EXTRACT-SCREW CONI W/L-HAND THREAD F/CER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803752 ↗
• MalfunctionNov 21, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, A CONICAL EXTRACTION SCREW BROKE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18186826 ↗
• MalfunctionAug 16, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND MONTH IN 2023, THE TIP WAS BROKE OFF. IT IS UNKNOWN WHEN WAS THE EVENT OCCURRED. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558818 ↗
• MalfunctionFeb 2, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SPN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER IN QUESTION WAS FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INTERACTION. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284014 ↗
• MalfunctionMay 21, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THAT SCREW REMOVAL EXTRACTORS WERE BROKEN AND DAMAGED DURING A DIFFICULT HARDWARE REMOVAL OF AN UNKNOWN PROXIMAL FEMUR PLATING CONSTRUCT. THEY ARE PLANNING TO REPLACE ALL OF THE DAMAGED PIECES. THE BROKEN PIECES WERE ALL SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT IS LINKED TO COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866504 ↗
• MalfunctionJun 29, 2020Break; Break

  IT WAS REPORTED THAT DURING A HARDWARE REMOVAL OF A SMITH AND NEPHEW INTERTAN NAIL ON (B)(6) 2020, ONE OF THE HEAD OF THE INTERTAN LAG SCREWS BROKE DURING THE REMOVAL PROCESS. A SERIES OF MULTIPLE ATTEMPTS TO EXTRACT THE LAG SCREW WAS MADE BUT UNSUCCESSFUL. THE SURGEON DECIDED TO DO A PROXIMAL FEMUR REPLACEMENT WHICH INVOLVED CUTTING THE NAIL OUT DUE TO NOT BEING ABLE TO REMOVE THE INTERTAN NAIL. DURING THE PROCESS AN INSTRUMENT FROM THE SCREW REMOVAL WAS USED TO TRY TO REMOVE THE LAG SCREW BUT THE TIP OF THE REPORTED CONICAL EXTRACTION SCREW BROKE OFF INTO THE LAG SCREW. ALL OF THE BROKEN FRAGMENTS OF THE CONICAL EXTRACTION SCREW WERE REMOVED EASILY FROM THE PATIENT. THE BROKEN SCREW REMOVAL TOOL DID NOT CAUSE ANY DISRUPTION OR HARM TO THE PATIENT OR CHANGE THE COURSE OF THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN LAG SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10208834 ↗
• MalfunctionOct 29, 2019Break; Break

  IT WAS REPORTED THAT, ON (B)(6) 2019, DURING A MEDIAL COLUMN FUSION AND TARSOMETATARSAL TMT ARTHRODESIS RIGHT FOOT. WHEN INSERTING A 4.5 MM HEADLESS COMPRESSION SCREW WITH POWER, THE COMPRESSION SCREW BROKE OFF AT THE TREAD SHAFT JUNCTION. THE SCREW WAS UNDER MUCH TORQUE WHEN IT BROKE. THE SURGEON SPENT 15 MIN TRYING TO REMOVE THE SCREW BUT WAS NOT SUCCESSFUL. 1/2 THE SCREW REMAINS IN THE PATIENT. IN THE PROCESS OF REMOVING THE SCREW, THE CONICAL EXTRACTION DEVICE FROM SCREW REMOVAL SET ALSO BROKE. THE VERY DISTAL TIP OF THIS ALSO REMAINS IN THE PATIENT. ADDITIONAL FIXATION WAS IMPLANTED AROUND THE BROKEN SCREW. THE PART OF THE SCREW THAT WAS REMOVED AND WILL NOT BE RETURNED. THERE WERE FRAGMENTS GENERATED AND EMBEDDED IN THE PATIENT'S BONE IN THE MIDDLE OF THE SECOND METATARSAL. THERE WERE A 15 MINUTES SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9250562 ↗
• MalfunctionSep 6, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT REMOVAL OF THE HIP CANNULATED SCREW. THE ORIGINAL IMPLANT DATE IS UNKNOWN AS IS THE REASON FOR THE EXPLANATION. DURING THE PROCEDURE, IT WAS NOTICED THAT THE THREADS ON THE TIP OF A CONICAL EXTRACTION SCREW WERE NOTICED TO BE STRIPPED AND CHIPPED AND NOT FUNCTIONING PROPERLY. ANOTHER DEVICE FROM ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THREE INTACT CANNULATED SCREWS WERE SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO FRAGMENTS GENERATED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: 7.3 MM CANNULATED SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A CONICAL EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7851365 ↗
• InjuryJul 12, 2018Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5077683; A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7683374 ↗
• MalfunctionJun 25, 2018Break; Break

  IT WAS REPORTED THAT THE TITANIUM (TI) CANCELLOUS EXPANSION HEAD SCREW BROKE DURING AN ANTERIOR CERVICAL DISCECTOMY (ACD) PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE, ONE OF THE FINS POPPED OFF AS THE SURGEON WENT TO BRING THE SCREW DOWN FLUSH WITH THE PLATE. THE SECOND FIN ALSO POPPED OFF IN TRYING TO RETRIEVE THE FIRST FIN. WHEN A CONICAL SCREW EXTRACTOR WAS USED, THE TIP OF THE EXTRACTOR BROKE OFF. THE SURGEON THEN USED NON-SYNTHES SURGICAL DRILL AND BURRED THE SCREW DOWN TO BE FLUSH WITH THE PLATE. THE SCREW WAS LEFT BEHIND THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: SPINE PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1); SURGICAL DRILL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A CONICAL EXTRACTION SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7635538 ↗
• InjuryJun 7, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF A PEDIATRIC OSTEOTOMY PLATE ON (B)(6) 2018. THE PLATE REMOVAL WAS A PATIENT¿S CHOICE AFTER A SUCCESSFUL HEALING. DURING THE PROCEDURE, THERE WAS A LOCKING SCREW FUSED INTO THE PLATE AND WHEN THE SURGEON ATTEMPTED TO REMOVE THE SCREW, THE HEAD STRIPPED. THE CONICAL EXTRACTOR WAS THEN USED BUT IT BROKE INSIDE THE SCREW. THE SURGEON WANTED TO SAW THE PLATE TO SEPARATE IT FROM THE SCREW; HOWEVER, THERE WAS NO SAW AVAILABLE IN THE HOSPITAL; THUS, THE PATIENT¿S INCISION SITE WAS CLOSED AFTER ABOUT FORTY-FIVE (45) MINUTES OF TRYING TO REMOVE THE PLATE. REPORTEDLY THIS EVENT RESULTED IN A FORTY (40) MINUTE SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE AND IN GOOD CONDITION. THE PLATE REMOVAL WAS DONE ON UNKNOWN DATE USING A SAW IN ANOTHER FACILITY. THIS REPORT IS FOR THE CONICAL EXTRACTION SCREW. THE PLATE AND SCREW WILL BE CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7577972 ↗
• MalfunctionFeb 13, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT HAD A PLANNED REMOVAL OF A COMPETITOR¿S HARDWARE (SCREWS) ON (B)(6) 2018. DURING THE PROCEDURE, THE SURGEON REMOVED ONE SCREW WITHOUT DIFFICULTY. WHEN HE ATTEMPTED TO REMOVE THE SECOND SCREW HE WAS HAVING DIFFICULTY. THEREFORE, THE SURGEON USED THE CONICAL EXTRACTION SCREW. DURING REMOVAL, THE TIP OF THE EXTRACTION SCREW BROKE OFF INTO THE SCREW AND THE IMPLANTED SCREW HEAD POPPED OFF. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT. THE SURGEON ATTEMPTED TO USE A HOLLOW REAMER TO REMOVE THE SCREW SHAFT AND THE TEETH FELL OFF OF THE HOLLOW REAMER INTO THE PATIENT. THOSE FRAGMENTS WERE NOT RETRIEVED. IT APPEARED THE RETAINED SHAFT OF THE SCREW WAS FUSED WITH THE PATIENT¿S BONE. THE MALFUNCTION OF THE COMPETITOR¿S SCREW LED TO ADDITIONAL SURGICAL INTERVENTION. THIS WAS LESS THAN A DESIRABLE OUTCOME. THE PATIENT WAS STABLE FOLLOWING SURGERY. SURGEON STATED THAT A 4.0MM CANNULATED HEXAGONAL SCREWDRIVER GOT TWISTED DURING THE SURGERY. IT IS UNKNOWN HOW OR WHEN THE DEVICE TWISTED. CONCOMITANT MEDICAL PRODUCTS: HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0MM SCREWS (309.065, LOT NUMBER UNKNOWN, QUANTITY 1), SPARE REAMER TUBE FOR HOLLOW REAMER (309.480, LOT NUMBER UNKNO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7267026 ↗
• MalfunctionJan 23, 2017Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2016, AFTER THE SCREW WAS INSERTED, SURGEON NOTICE THAT THE SCREW HEAD WAS BROKEN. A CONICAL SCREW EXTRACTOR WAS BROUGHT IN TO REMOVE THE BROKEN SCREW. THE REPORTER STATED THAT SCREW WAS REMOVED ATTACHED TO THE TIP OF THE EXTRACTOR IN ONE PIECE. ALL FRAGMENTS WERE RETRIEVED. HOWEVER, WHILE THE SURGERY WAS STILL IN PROGRESS, THE REPORTER NOTICED THAT THE EXTRACTOR TIP WAS BROKEN INSIDE THE SCREW. THE EXTRACTOR IS NOW IN TWO PIECES WITH THE TIP INSIDE THE SCREW, MEANWHILE, ANOTHER SCREW WAS USED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS REPORTED AS STABLE. THIS COMPLAINT INVOLVE 2 PARTS. THIS REPORT IS 1 OF 2 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6269879 ↗
• MalfunctionJan 20, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2016, THAT THE SURGEON WAS REMOVING A 7.3MM CANNULATED SCREW AND THE CANNULATED HEXAGONAL SCREWDRIVER TIP BROKE OFF AND THE TIP OF THE CONICAL EXTRACTION SCREW BROKE OFF. THE SURGEON WAS UNABLE TO REMOVE THE SCREW. THE SURGICAL PROCEDURAL OUTCOME IS UNAVAILABLE. THERE WAS A 5 MINUTE SURGICAL DELAY. THE PATIENT OUTCOME/STATUS IS UNAVAILABLE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. SALES CONSULTANT INDICATES THAT THERE WAS AN UNKNOWN TIME DELAY. THIS COMPLAINT INVOLVES 2 DEVICES. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN SCREW 7.3MM CANNULATED PART# UNKNOWN, LOT#-UNKNOWN, QUANTITY#1). THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6268371 ↗