NA 03.010.093Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886982067647), received between Aug 15, 2018 and Apr 28, 2026 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE CABLE PASSER WAS JAMMED WHERE IT CANNOT BE LOCKED OR UNLOCKED. THE ROD PUSHERS ARE ALL BROKEN AT THE TIP AND TOWARDS THE END WILL NOT FIT IN THE REAMERS. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020607 ↗
• MalfunctionApr 28, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE CABLE PASSER WAS JAMMED WHERE IT CANNOT BE LOCKED OR UNLOCKED. THE ROD PUSHERS ARE ALL BROKEN AT THE TIP AND TOWARDS THE END WILL NOT FIT IN THE REAMERS. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020551 ↗
• MalfunctionApr 28, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE CABLE PASSER WAS JAMMED WHERE IT CANNOT BE LOCKED OR UNLOCKED. THE ROD PUSHERS ARE ALL BROKEN AT THE TIP AND TOWARDS THE END WILL NOT FIT IN THE REAMERS. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020231 ↗
• MalfunctionApr 21, 2026Material Deformation

  IT WAS REPORTED THAT THE REAMING ROD PUSHERS HAVE BECOME BENT/DEFORMED THROUGH REGULAR USE AND ARE UNABLE TO BE USED WITHOUT BINDING. THERE WAS NO PATIENT HARM OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944746 ↗
• MalfunctionApr 21, 2026Material Deformation

  IT WAS REPORTED THAT THE REAMING ROD PUSHERS HAVE BECOME BENT/DEFORMED THROUGH REGULAR USE AND ARE UNABLE TO BE USED WITHOUT BINDING. THERE WAS NO PATIENT HARM OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944745 ↗
• MalfunctionJan 16, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ROD PUSHER WAS DEFORMED AT THE TIP, NOT ALLOWING IT TO BE SLID INTO THE BACK OF FLEXIBLE REAMER. T-HANDLE CHUCK WAS WORN AND WHEN TIGHTENED DOWN, DID NOT ADEQUATELY GRASP REAMING ROD. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094609 ↗
• MalfunctionDec 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT REAMING ROD WAS DAMAGED DURING SURGERY. THE ORBITRATOR WAS ALSO DAMAGED DURING SURGERY AND BECAME BENT. NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779428 ↗
• MalfunctionDec 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT THERE WERE SEVERAL INSTRUMENTS THAT WERE DAMAGED AND NEEDED TO BE REPLACED. THE ROD PUSHER F/REAMROD W/HEX-SCREWDRIVER ØIS WAS UNABLE TO BE USED. THE GUIDE SLEEVE YELL HAD THE POINTED END BENT AND WOULD NOT ALLOW A DRILL TO GO THROUGH IT SMOOTHLY. THE MONOBLOC FLEX REAMER STD CASE LID WAS BENT AND UNABLE TO BE PUT ONTO THE CASE. THE TIP OF THE PLIERS WERE STRIPPED AND UNABLE TO GRAB THE NAILS. BECAUSE THEY WERE STRIPPED, BOTH OF THESE WERE DISCARDED BY THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT. ALL OF THESE ITEMS WERE NOTICED TO BE DAMAGED AFTER THE DECONTAMINATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693631 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE LONG RETENTION PIN IS MISSING ITS LITTLE THREADED PART FROM THE TIP OF IT, AND THE ROD PUSHER IS BENT. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345481 ↗
• InjuryMay 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE THE IMPLANTS WERE DAMAGED AND WHEN SURGEON TRIED TO REMOVE THE INSTRUMENT, IT WAS IMPOSSIBLE TO RELEASE THE NAIL FROM THE INSTRUMENT, SO HE HAD TO REMOVE ALL THE IMPLANTS AND LEAVE THE PATIENT WITH THE INITIAL INJURY. SURGEON PLANNED TO REOPERATE PATIENT ON (B)(6) 2025. ADDITIONALLY, WHEN REVIEWING THE NEW PARTS INVOLVED IN THE SURGERY PERFORMED, IT WAS NOTICED THAT THE INSERTION ARCH WAS FUSED TO THE TFNA NAIL BY MEANS OF THE CONNECTION SCREW FOR THE INSERTION ARCH AND HAS INTERNAL SCRATCHES, ALONG WITH THE IMPLANTS THAT WERE REMOVED DUE TO THIS NEW PART. IT WAS IMPOSSIBLE TO DISASSEMBLE THE INSERTION ARCH AND THE NAIL TO SUCH AN EXTENT THAT THE T-HEAD SCREWDRIVER THAT SECURES THE CONNECTING SCREW BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21949132 ↗
• MalfunctionJun 23, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, WHILE INVENTORYING SETS IT WAS NOTICED THAT SOME INSTRUMENTS WERE AFFECTED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS UNKNOWN MEDICAL INTERVENTION. THIS REPORT INVOLVES ONE (1) REAMING ROD PUSH ROD WITH BALL HANDLE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192668 ↗
• MalfunctionMay 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ROD PUSHER DOES NOT FIT INTO REAMING ROD AND NEED TO BE REPLACED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) REAMING ROD PUSH ROD WITH BALL HANDLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976491 ↗
• MalfunctionApr 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE OF A BREAKAGE & REPAIR. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE 1 ROD PUSHER F/REAMROD W/HEX SCREWDRIVER Ø. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691425 ↗
• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT ON 2/27/2023, THE REAMING ROD PUSH ROD WITH BALL HANDLE BROKEN IN HALF. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) REAMING ROD PUSH ROD WITH BALL HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539470 ↗
• MalfunctionFeb 23, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE SURGERY IT WAS NOTED THAT THE METAL PRONGS AT THE TIP HAD BECOME DEFORMED AND COULD NO LONGER PROPERLY RETAINED THE REAMER HEADS THAT THEY WERE DESIGNED TO RETAIN. THE ITEM WAS DEEMED TO BE NO LONGER FUNCTIONAL, AND WAS SUBSEQUENTLY DISCARDED. A REPLACEMENT IS REQUIRED. IT WAS IDENTIFIED BY MEDICAL DEVICE REPROCESSING STAFF DURING ROUTINE INSPECTION, THE SECOND COMPLAINED ITEM TO BE SIGNIFICANTLY DISCOLORED ON THE HANDLE, AND THE THIN METAL SHAFT WAS BENT AT AN INCORRECT ANGLE. THIS ITEM WAS DEEMED TO BE NO LONGER FUNCTIONAL AND WAS DISCARDED. A REPLACEMENT IS REQUIRED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) REAMING ROD PUSH ROD WITH BALL HANDLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16431948 ↗
• MalfunctionFeb 17, 2023Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401569 ↗
• MalfunctionFeb 17, 2023Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401216 ↗
• MalfunctionMay 6, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF THE BACK UP DEVICES IT WAS DISCOVERED THAT THE GOLD PEG OF ONE (1) RECON LOCKING AIMING ARM FOR LFN NAILS-EX HAS SNAPPED OFF, THE THREADS OF ONE (1) EXTRACTION SCREW FOR TI FEMORAL & TIBIAL NAILS AND ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR ARE STRIPPED, AND ONE (1) DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS WAS STUCK IN PLACE. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER INVESTIGATION, THE DEVICE WAS FOUND TO BE DISCOLORED FROM THE BALL HANDLE AND DEFORMED FROM THE SHAFT. THIS REPORT IS FOR A REAMING ROD PUSH ROD WITH BALL HANDLE. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310804 ↗
• MalfunctionNov 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN SURGERY, THE DRILL BIT BROKE. THE DRILL WAS USED AS A ROTATIONAL REFERENCE MARKER. THE SURGEON TRIED PASSING A FLEXIBLE REAMER PAST. THE DRILL BIT BROKE INTO TWO SEGMENTS WHEN THE REAMER ENGAGED. BOTH SEGMENTS WERE RETRIEVED. AND, REAMING ROD PUSHER WAS STUCK WHEN USED TO CLEAR OUT BONE FROM A CANNULATED DRILL. THE ROD PUSHER WAS PULLED OUT WITH FORCE, REVEALING A BENT WIRE SHAFT. THERE WAS A SURGICAL DELAY OF FIFTEEN MINUTES. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882711 ↗
• MalfunctionAug 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF THE INSTRUMENTS AFTER GOING TO DECONTAMINATION PROCESS, IT WAS NOTICED THAT A TROCAR WAS BENT AND WAS INADVERTENTLY PLACED IN THE SHARP¿S CONTAINER, A REAMING ROD PUSH ROD WITH BALL HANDLE WAS ALSO FOUND BENT AND HAS SCUFF MARKINGS ON IT WHERE IT LOOKS LIKE IT IS GETTING JAMMED UP IN THE DRILLS BECAUSE IT IS BENT, AND THE WHOLE TIP OF A DEPTH GAUGE BROKE OFF COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) REAMING ROD PUSH ROD WITH BALL HANDLE THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268631 ↗
• MalfunctionMay 11, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR AN INTRAMEDULLARY NAIL INSERTION SURGERY. DURING THE SURGERY, IT WAS NOTICED THAT THE TIPS OF THE SCREWDRIVERS WERE ROUNDED OFF. AS WELL THE ROD PUSHER END APPEARED TO HAVE BEEN BROKEN OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) REAMING ROD PUSH ROD WITH BALL HANDLE. THIS REPORT IS 3 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809099 ↗
• MalfunctionFeb 1, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE TIP OF THE REDUCTION HEAD-ANGLED BROKE OFF. THE SOFT TISSUE BONE REDUCTION FORCEPS WITH BALL TIPS AND SOFT TISSUE ATTACHMENT J-SHAPE F/REDUCTION FORCEPS BALL AND PLASTIC PIECE BROKE. THE REDUCTION TOOL/CURVED WITH QUICK COUPLING WOULDN¿T ATTACH TO T HANDLE QUICK COUPLING (QC); IT SEEMED TO BE CROSS THREADED. TWO (2) 1.8MM COAXIAL DRILL GUIDES CROSS THREADED. TWO (2) RETRACTOR FOR SCIATIC NERVE WERE BENT. AND THE TIP OF THE REAMING ROD PUSH ROD BROKE OFF. ALL EQUIPMENT WAS USED DURING SURGERY AND HAD MALFUNCTIONED. SURGERY WAS DELAYED FIVE TO 10 (5-10) MINUTES. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A REAMING ROD PUSH ROD WITH BALL HANDLE. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262313 ↗
• MalfunctionNov 16, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS (B)(6) SITE, IT WAS OBSERVED THAT THE REAMING ROD PUSH ROD WITH BALL HANDLE WAS BENT. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) REAMING ROD PUSH ROD WITH BALL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10845238 ↗
• MalfunctionJul 21, 2020Material Integrity Problem; Material Integrity Problem

  DURING MANUFACTURER'S INVESTIGATION OF THE RECEIVED IMAGE IT WAS IDENTIFIED THAT THE DEVICE IS BENT AT THE TIP. THIS CONDITION WAS REEVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302420 ↗
• MalfunctionJul 2, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE REAMING ROD PUSH WITH BALL HANDLE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 REAMING ROD PUSH ROD WITH BALL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10225656 ↗