NA 309.450Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982185730), received between Jan 10, 2017 and Mar 18, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 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 A PTP PLATE WHICH WAS IMPLANTED ON (B)(6) 2023. WHILE A REAMER WAS BEING USED TO REMOVE SCREWS, IT WAS BROKEN OFF. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE HOLLOW-REAMER-COMPL ANT ICLOCKWISE CUTTIN THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18921924 ↗
• MalfunctionFeb 13, 2024Device Slipped; Device Slipped

  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)HOLLOW-REAMER-

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695709 ↗
• MalfunctionAug 30, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED ON THAT ON (B)(6) 2022, THE SURGEON WAS USING A SCREW REMOVAL SET THAT IS OWNED BY THE ANIMAL HEALTH TEAM. THE SURGEON BROKE THE BASE OF ONE OF THE HOLLOW REAMERS. THE FAILURE WAS THROUGH THE HOLE IN THE THREADED BASE / DRILL ATTACHMENT AND NOT THE HOLLOW REAMER TUBE ITSELF. THE SURGEON BELIEVED THAT THE FAILURE HAPPENED AS THE SURGEON HAD TO REAM QUITE FAR ALONG THE SCREW. AFTER REAMING TO THIS DEPTH, THE SCREW BACKED OUT WITH THE EXTRACTION BOLT QUITE EASILY AND THE CASE WAS COMPLETED. THIS REPORT INVOLVES ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER (309.450). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319546 ↗
• 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 12175056 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING SURGICAL PROCEDURE FOR A REMOVAL OF HARDWARE AND REPAIR RIGHT FEMUR FRACTURE, THE TIP OF THE HOLLOW REAMER COMPLETE HAD TWO (2) PIECES BREAK OFF. BOTH PIECES RETRIEVED BY THE SURGEON. THERE IS MINOR SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9322966 ↗
• MalfunctionJun 13, 2019Break; Break

  UPDATE: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A HIP REVISION SURGERY TO REMOVE THE IMPLANTS DUE TO NONUNION. THERE WAS A SURGICAL DELAY OF THREE (3) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN.  THIS (B)(4) CAPTURES INTRA-OPERATIVE EVENT, WHILE (B)(4) WAS CREATED TO CAPTURE POST-OPERATIVE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8698029 ↗
• InjuryOct 31, 2017Break; Break

  IT WAS REPORTED THAT INITIALLY A PATIENT UNDERWENT A PLACEMENT OF A MEDIAL MALLEOLAR SCREW FOR AN ANKLE VALGUS ON AN UNKNOWN DATE TO CORRECT A DEFORMITY. A HARDWARE REMOVAL WAS SCHEDULED ON (B)(6) 2017 DUE TO THE DEFORMITY HEALING. DURING THE REMOVAL, A 4.0MM CANNULATED SCREW STRIPPED. AS THE SURGEON WAS REMOVING THE SCREW FROM THE MEDIAL MALLEOUS, THE SCREW HEAD STRIPPED. THE SURGEON USED PLIERS TO BACK THE SCREW OUT. THE HEAD THEN BROKE OFF, SO THE SURGEON USED A TREPHINE TO OPEN AROUND THE SHAFT OF THE SCREW. THE TREPHINE THEN BROKE OFF INSIDE THE PATIENT. THE SURGICAL TEAM THEN USED A CONICAL EXTRACTOR TO REMOVE THE SCREW SHAFT. THE SCREW THEN BROKE OFF INSIDE THE PATIENT. USING THE HARDWARE REMOVAL TOOLS TO EXTRACT THE SCREW, THE SURGERY WAS ABLE TO BE COMPLETED WITH THE REMOVAL OF THE ENTIRE SCREW. THERE WAS ABOUT A TEN (10) MINUTE SURGICAL DELAY. THE PATIENT STATUS IS GOOD. CONCOMITANT DEVICES REPORTED: PLIERS (PART # UNKNOWN, LOT # UNKNOWN, QTY 1), CONICAL EXTRACTOR (PART # UNKNOWN, LOT # UNKNOWN, QTY 1); HARDWARE REMOVAL TOOLS (PART # AND LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) HOLLOW REAMER-COMPLETE FOR 4.5MM SCREWS. THIS IS REPORT 3 OF 4 FOR COMPLAIN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6991514 ↗
• MalfunctionJan 10, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT A HOLLOW REAMER FELL APART WHEN TRYING TO GET ITS PART UNTWISTED. THE FACILITY HAD A DIFFICULT TIME ATTEMPTING TO PULL THE REAMER APART TO PUT IT INTO THE SET ON (B)(6) 2016. THE SPARE REAMER TUBE WOULD NOT SEPARATE FROM THE HOLLOW REAMER. THEY CONTACTED THE SALES CONSULTANT WHO MADE AN ATTEMPT TO GET THE REAMER APART. WHILE TWISTING THE COMPONENTS THE REAMER FELL APART. WHEN THE REAMER WAS FINALLY DISASSEMBLED, THE CENTERING PIN BROKE. THERE WAS NO CASE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLLOW REAMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6236388 ↗