NA 351.706SRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886982193858), received between Mar 26, 2018 and May 7, 2025 — classified as 6 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT WAS HAVING A TIBIAL NAIL PLACED FOR A DISTAL THIRD TIBIA FRACTURE. A REAMING ROD WAS OPENED STERILE TO THE BACK TABLE. WHILE THE SURGEON WAS PLACING A SLIGHT BEND ON THE DISTAL PORTION, THE TIP OF THE REAMING ROD BROKE OFF. VERY LITTLE PRESSURE WAS USED BEFORE THE BALL TIP BROKE OFF. NO PATIENT INVOLVEMENT, AS IT HAPPENED ON THE BACK TABLE. ALL PIECES WERE REMOVED FROM STERILE FIELD AND DISCARDED. SURGERY COMPLETED SUCCESSFULLY. PROCEDURE SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977145 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON WAS ATTEMPTING TO PUT A SMALL BEND ON A BALL TIP REAMING ROD AND THE TIP BROKE. ANOTHER REAMING ROD WAS OPENED AND THE SAME THING HAPPENED AGAIN. NO INJURY OCCURRED TO STAFF OR PATIENT. NO FRAGMENTS REMAINED IN THE PATIENT. A THIRD ROD WAS OPENED AND THE CASE PROCEEDED. THERE WAS SURGICAL DELAY OF LESS THAN FIVE MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20518159 ↗
• MalfunctionOct 17, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WERE NO BROKEN FRAGMENTS RETAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473808 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, MELTED PLASTIC ON END OF BALL TIP WIRE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.5 REAMING ROD BALL TIP/950-STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272014 ↗
• InjuryJul 9, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE REAMING ROD BROKE IN THE FEMORAL CANAL WHILE INSERTING THE RFNA NAIL. THERE WAS A SURGICAL DELAY OF 60-90 MINUTES. THE BROKEN ROD WAS RETRIEVED OUT OF THE PROXIMAL END OF THE FEMUR. AN ADDITIONAL INCISION WAS MADE TO RETRIEVE THE ROD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701820 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE REAMING RODS IN QUESTION BROKE. THE SURGEON PREFERS A BEND AT THE END OF THE REAMING ROD, AND THE RODS BROKE WHEN STAFF ATTEMPTED TO BEND THEM. A THIRD REAMING ROD OF THE SAME TYPE WAS OPENED, AND STAFF WERE ABLE TO BEND IT SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT IMPACT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18667080 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE REAMING RODS IN QUESTION BROKE. THE SURGEON PREFERS A BEND AT THE END OF THE REAMING ROD, AND THE RODS BROKE WHEN STAFF ATTEMPTED TO BEND THEM. A THIRD REAMING ROD OF THE SAME TYPE WAS OPENED, AND STAFF WERE ABLE TO BEND IT SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT IMPACT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18667077 ↗
• MalfunctionJun 5, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCRUB TECH ATTEMPTED TO ADD BEND INTO THE BALL TIP GUIDE WIRE, WHICH THEN HAD BALL TIP GUIDE WIRE SNAP NEAR THE BALL END OF THE WIRE. AS THE NEW WIRE WAS OPENED, WE ONCE AGAIN ADDED A BEND TO THE WIRE, THE SCRUB TECH STATED THAT HE COULD FEEL THE NEW WIRE ALSO WANTING TO SNAP. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE ACTION WAS TAKEN AS OPENED ANOTHER BALL TIP GUIDE WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO FRAGMENTS WERE GENERATED. THE FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 2.5 REAMING ROD BALL TIP/950-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059984 ↗
• MalfunctionJun 2, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, TWO OF THE 2.5 BALL TIP - 950MM BALL TIPS WERE OPENED TO BE INSERTED INTO THE PATIENT. THE SURGEON/SCRUB TECH BENT THE TIP OF THE WIRE SLIGHTLY WITH A PAIR OF THE PLIERS WHICH CAUSED THE BALL TIP TO SNAP. AFTER THE FIRST BALL TIP BROKE, THEY PROCEEDED TO OPEN A SECOND WHICH IMMEDIATELY HAD SNAPPED WHILE ADDING A VERY SLIGHT BEND TO THE WIRE. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT CONSEQUENCES. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR (1) 2.5 REAMING ROD BALL TIP/950-STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052133 ↗
• MalfunctionJun 2, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, TWO OF THE 2.5 BALL TIP 950MM BALL TIPS WERE OPENED TO BE INSERTED INTO THE PATIENT. THE SURGEON/SCRUB TECH BENT THE TIP OF THE WIRE SLIGHTLY WITH A PAIR OF THE PLIERS, WHICH CAUSED THE BALL TIP TO SNAP. AFTER THE FIRST BALL TIP BROKE, THEY PROCEEDED TO OPEN A SECOND, WHICH IMMEDIATELY HAD SNAPPED WHILE ADDING A VERY SLIGHT BEND TO THE WIRE. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AND THERE WERE NO PATIENT CONSEQUENCES. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR (1) 2.5 REAMING ROD BALL TIP/950-STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052009 ↗
• InjuryMay 23, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS USING THE RIA 2 (REAMER IRRIGATOR ASPIRATOR) BONE HARVESTING KIT AND BITS THAT GO WITH IT. A PRODUCT REPRESENTATIVE WAS PRESENT FOR THE PROCEDURE TO ENSURE PROPER ASSEMBLY AND USE OF THE PRODUCT. DURING THE PROCEDURE, SHARDS OF THE BITS KEPT BREAKING OFF IN THE PATIENT¿S BONE AND WERE NOT ABLE TO BE RECOVERED. THIS ISSUE HAPPENED WITH ALMOST EVERY DEVICE USED IN THE PROCEDURE. WHEN THE KIT WAS BEING WITHDRAWN, PIECES OF WHAT LOOKED TO BE THE PLASTIC SHEATH SHREDDED AND TAKEN OUT OF THE INCISION. PER THE OR NOTE: WE ATTEMPTED TO START REAMING WITH THE 10 MM SYNTHES RIA, HOWEVER THE REAMER WOULD NOT PASS BEYOND THE LESSER TROCHANTER. THE RIA WAS REPLACED WITH AN 8.5 MM REAMER. THE REAMER WAS ADVANCED WITHOUT DIFFICULTY OVER THE BALL-TIPPED GUIDE ROD TO THE DISTAL FEMORAL PHYSIS. THE 10 MM RIA WAS AGAIN USED. THE REAMER WAS ADVANCED TO THE LEVEL OF THE DISTAL FEMORAL PHYSIS AND DURING EXTRACTION IT WAS NOTED THAT THE CUTTING HAD HAD SEPARATED FROM THE REAMER, LEAVING 2 SMALL METAL TINES BEHIND IN THE FEMORAL DIAPHYSIS WHICH WERE IRRETRIEVABLE. A 10.5 MM RIA REAMER WAS ADVANCED TO PROXIMALLY THE MIDDLE OF THE DIAPHYSIS BEFORE THE REA

  Patient problems: Foreign Body In Patient

  MAUDE report 16987918 ↗
• MalfunctionMar 28, 2023Break; Break

  IT WAS REPORTED THAT ON AN (B)(6) 2023 WHILE REAMING OVER A 2.5MM BALL TIP GUIDE WIRE TO INSERT A TIBIAL NAIL ADVANCED USING LONG MONOBLOC REAMER SYSTEM, SIGNIFICANT RESISTANCE WAS MET WHILE ATTEMPTING TO PASS FIRST REAMER (8MM DIAMETER). STRYKER SYSTEM 8 POWER WAS USED ON DRILL SETTING FOR THIS PORTION OF PROCEDURE. FOR ENTIRE PROXIMAL HALF OF THE TIBIA DURING REAMING WITH THIS INSTRUMENT, SIGNIFICANT RESISTANCE WAS MET WITH REAMER SHAFT AND HEAD. REAMER WAS SUCCESSFULLY PASSED DOWN LENGTH OF FEMUR WITH RELENT OF RESISTANCE AFTER EXITING DIAPHYSIS OF TIBIA ON DISTAL END. UPON REMOVING 8MM MONOBLOC REAMER FROM CANAL AND BALL TIP GUIDE WIRE, FRONT END OF REAMER AND FIRST SEGMENT OF SHAFT CONNECTED TO REAMER HEAD WERE VISUALIZED AS DISCONNECTED FROM REMAINDER OF REAMER PIECE AS THIS FRAGMENT FELL TO GROUND WHEN TRANSFERRING REAMER TO BACK TABLE. FRAGMENTS WERE GENERATED, HOWEVER NO PIECES WERE LEFT IN PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 2.5 REAMING ROD BALL TIP/950-STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630901 ↗
• MalfunctionMay 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SYNTHES HARDWARE REMOVAL. DURING THE REAMING PROCESS, WHEN THE SURGEON ATTEMPTED TO BEND THE TIP OF A 2.5 REAMING ROD AND THE TIP BROKE OFF. ANOTHER REAMING ROD WAS OPENED, AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE 2.5 REAMING ROD BALL TIP/950-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14457431 ↗
• MalfunctionMar 8, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS REMOVING ONE (1) 3.0MM REAMING GUIDE ROD USING UNIVERSAL CHUCK, THE WELD APPEARED TO BREAK AND THE T-HANDLE WAS UNABLE TO RELEASE THE GUIDE ROD. RETRIEVED OTHER GUIDE TODAY AND T-CHUCK. THE SURGERY WAS DELAYED 5 MINUTES BUT SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE. DURING INVESTIGATION OF THE RETURNED DEVICE, IT WAS NOTED THE REAMING ROD IS BROKEN. THIS REPORT IS FOR A REAMING ROD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690401 ↗
• InjuryNov 16, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, THE TIP OF 2.5 BALL TIPPED GUIDEWIRE BROKE OFF IN PATIENT'S FEMUR. THE END OF WIRE WAS PRE-BENT PRIOR TO PLACING IN PATIENT AND THE WIRE BROKE WHERE IT HAD BEEN BENT. THE SURGEON DID NOT RETRIEVE THE BROKEN FRAGMENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12824362 ↗
• InjuryNov 9, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, USING REAMER IRRIGATOR ASPIRATOR (RIA) II FOR FEMUR FRACTURE, A 1MM REAMER FOR 9MM NAIL WAS USED. THE SURGEON WAS AGGRESSIVELY REAMING WITH RIA 2 EVEN AFTER BEING INSTRUCTED ON PROPER USAGE SINCE THE CORTICAL BONE WAS DENSE. A BEND WAS PLACED DISTALLY NEAR THE END OF THE BALL TIP REAMING ROD. THE SURGEON STILL TRIED ADVANCING THE RIA 2 BUT WAS NOT ABLE TO ADVANCE ANYMORE. HE THEN FINISHED REAMING. IT WAS OBSERVED THAT IF THERE IS A BEND IN THE REAMING ROD YOU CANNOT ADVANCE THE REAMER OVER THE REAMING ROD. IT WAS ALSO DETERMINED THAT THE REAMER HEAD BROKE BECAUSE AFTER THE REAMER HEAD WAS RETRIEVED THERE WERE REMNANTS THAT SHOWED UP ON THE IMAGE IN THE DISTAL FEMUR. THERE WAS A (5) MINUTES SURGICAL DELAY. THE PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES (1) 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12782504 ↗
• MalfunctionSep 7, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE REAMING ROD WAS BENT THEN PASSED THROUGH THE CANNULATED AWL INTO THE TIBIA, WHILE THE REAMING ROD ENTERED THE TIBIAL CANAL AND HIT THE POSTERIOR CORTEX AND THE TIP BROKE OFF. FRAGMENTS WERE GENERATED, AND WERE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TEN(10) - FIFTEEN(15) MINUTES DELAY. CONCOMITANT DEVICE REPORTED: CANNULATED AWL (PART# 03.010.040, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.5 REAMING ROD BALL TIP/950-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433642 ↗
• MalfunctionAug 3, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE BALL TIP ON GUIDE WIRE BROKE OFF BEFORE INSERTING INTO PATIENT¿S BONE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.5 REAMING ROD BALL TIP/950-STERILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268698 ↗
• MalfunctionAug 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE REAMING ROD STUCK IN T-CHUCK AND COULD NOT BE REMOVED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267588 ↗
• InjuryApr 29, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE REAMING ROD SNAPPED HALF OF THE REAMER AND WAS ABLE TO REMOVE IT. IN THE SECOND PART OF THE INCIDENT, PUTTING THE REAMING ROD DOWN, CUTTING THE FRONT REAMER HEAD WHICH ENDED UP SHATTERING INSIDE THE PATIENT. SURGEON WAS NOT ABLE TO RETRIEVE THE PIECES OF THE SHATTERED REAMER AND HAD TO SPLIT THE FRACTURE FURTHER TO PULL THE REAMING ROD OUT. SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES DELAY. CONCOMITANT DEVICE REPORTED: UNK - REAMER: (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11749925 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 THE TWO REAMING ROD WITH BALL TIP, BOTH OF THESE GUIDE WIRES THE ENDS OF GUIDE WIRE SNAPPED OFF. THE GUIDE WIRE WAS BROKE. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE. THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11323956 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 THE TWO REAMING ROD WITH BALL TIP, BOTH OF THESE GUIDE WIRES THE ENDS OF GUIDE WIRE SNAPPED OFF. THE GUIDE WIRE WAS BROKE. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE. THIS IS REPORT 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11323909 ↗
• MalfunctionNov 18, 2019Break; Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A TIBIAL NAIL SURGERY ON AN UNKNOWN DATE, A REAMING ROD WITH BALL TIP HAD BROKE WHEN AN OPERATING ROOM STAFF ATTEMPTED TO PUT A BEND TO THE END OF THE ROD USING A UNIVERSAL CHUCK WITH T-HANDLE. THE REAMING ROD WAS INSERTED THROUGH THE CANNULATION IN THE UNIVERSAL CHUCK WITH T-HANDLE WITH THE BALL-TIP END PROTRUDING APPROXIMATELY 20CM. THE CHUCK WAS TIGHTENED TO SECURE THE REAMING ROD AND THE TIP OF THE REAMING ROD WAS PRESSED AGAINST THE OR BACK TABLE TO ATTEMPT TO CREATE A SLIGHT BEND IN THE ROD. THIS PROCESS IS WHAT THIS CUSTOMER USUALLY USES TO BEND THE 2.5MM REAMING RODS. THE SURGERY WAS COMPLETED BY USING ANOTHER REAMING ROD. HOWEVER, THERE WAS NO ATTEMPT IN BENDING THE NEW REAMING ROD. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNIVERSAL CHUCK WITH T-HANDLE (PART# 393.10, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9335248 ↗
• MalfunctionNov 15, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE BROKE WHEN OPERATING ROOM STAFF WAS ATTEMPTING TO PUT A BEND INTO THE END OF THE ROD PRIOR TO THE START OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) HIP NAIL CASE. THE ISSUE OCCURRED WHEN THE OPERATING ROOM (OR) WAS BEING SET UP FOR THE CASE, PRIOR TO THE PATIENT BEING IN THE ROOM. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9330540 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE TO ADDRESS ALLEGATIONS OF PSEUDOTUMOR, LOOSENING OF CUP, FRACTURE (BONE), METAL WEAR AND METALLOSIS. A NON-SYNTHES DEVICES WERE IMPLANTED ALONG WITH A SYNTHES DEVICE THAT WAS ONLY USED BUT NOT IMPLANTED DURING THE FIRST REVISION. ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY REVISION ADDRESSING ALLEGATION OF INFECTION REQUIRING ANTIBIOTICS. NO SYNTHES DEVICE WAS INVOLVED DURING THE PROCEDURE. THIS COMPLAINT INVOLVES ONE (1) DEVICE ONLY. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: Discomfort; No Code Available; Pain; Unspecified Infection

  MAUDE report 9322865 ↗