NA 03.404.000SRecalls & reported problems
Synthes GmbH · RIA 2 BONE HARVESTING KIT 520MM STERILE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes RIA 2 bone harvesting kit is used to ream and collect bone graft from the femur during orthopedic surgery. Its reports mostly describe parts breaking or deforming mid-procedure — reamer heads snapping off, sometimes staying in the patient, and plastic sleeves and seals melting or warping from pressure and heat, which at times delayed surgery. There are 58 reports, with13 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 58
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10886982274236), received between Apr 29, 2020 and Jun 9, 2026 — classified as 13 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Break” (51 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.
Reports received per month
Most reported problems
Device problems
- Break51
- Entrapment of Device10
- Device-Device Incompatibility5
- Material Deformation3
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Contamination /Decontamination Problem1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Foreign Body In Patient10
- No Consequences Or Impact To Patient6
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hemorrhage/Blood Loss/Bleeding1
- Injury1
- No Code Available1
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Break
IT WAS REPORTED THAT THE REAMER HEAD WAS BROKEN AND THE RIA SLEEVE BURNT. THERE WAS NO SURGICAL DELAY. ANOTHER DEVICE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443097 ↗MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN DURING REAMING (YELLOW PART).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844440 ↗MalfunctionApr 6, 2026Break
IT WAS REPORTED THAT THE REAMER HEAD F/RIA 2 Ø13 BROKE OFF INTO THE PATIENT, AND NOT ALL FRAGMENTS WERE RETRIEVED. THE RIA 2 BONE HARVESTING KIT L520 ALSO BROKE, BUT ALL FRAGMENTS WERE RETRIEVED. THE DRIVE SHAFT F/RIA 2 L520 REQUIRED INSPECTION DUE TO CONTAMINATION, AND IT WAS UNCLEAR IF IT WAS BROKEN. THE EVENT DESCRIPTION INDICATES THAT THE REAMER HEAD F/RIA 2 Ø13 WAS EMBEDDED WITHIN THE PATIENT, WHILE THE RIA 2 BONE HARVESTING KIT L520 AND DRIVE SHAFT F/RIA 2 L520 WERE NOT ASSOCIATED WITH RETAINED FRAGMENTS. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR INVOLVEMENT FOR ANY OF THE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24789512 ↗MalfunctionFeb 26, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2026 THAT DURING THE CASE IT APPEARS THAT A PORTION OF THE RIA2 MELTED. IT WAS A BIT HUNG UP ON A BONY LEDGE AND GENERATING HEAT. RIA DRIVESHAFT APPEARED IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454602 ↗MalfunctionDec 30, 2025Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE PATIENT HAD A PROPHYLACTIC PROXIMAL FEMUR FRACTURE, WITH INCREDIBLY DENSE, HARD BONE AS A RESULT OF THE TUMOR. UPON REAMING THE CANAL WITH THE RIA 2 KIT, THE PLASTIC END OF THE REAMING TUB BECAME TWISTED AND WARPED DUE TO THE INTENSE PRESSURE NEEDED TO REAM. BECAUSE OF THIS, WE WERE NOT ABLE TO FULLY PASS THE REAMER PAST THE ISTHMUS. THE MONOBLOC REAMERS WERE SUCCESSFULLY USED TO COMPLETE THE CASE. ADDITIONALLY, THE STEPPED REAM F/TFNA HELICAL BLADE+SCR F/ DRILL BIT CHIPPED AT THE END DURING DRILLING OF THE DENSE BONE, BUT THIS DID NOT AFFECT THE SUCCESSFUL COMPLETION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927455 ↗MalfunctionSep 18, 2025Break; Break
IT WAS REPORTED THAT THE RIA 2 WAS USED IN A CASE. THE SURGEON WAS FORCEFULLY DRIVING THE RIA REAMER INTO THE IM CANAL AND THE PLASTIC SLEAVE OF THE RIA 2 SHAFT GOT BUNCHED UP AND IMPEDED THE FLOW OF THE GRAFT THAT RIA WAS TRYING TO INTAKE. A NEW RIA NEEDED TO BE OPENED. STAFF REMINDED THE SURGEON TO USE LESS FORCE. SURGICAL DELAY OF 15 MINS. NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084164 ↗MalfunctionSep 5, 2025Break; Break
DURING A RIA 2 PROCEDURE, THE DRIVER SHAFT FROM THE BONE HARVESTING KIT WAS BROKEN. THIS WAS NOTICED AT THE END OF THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22983325 ↗MalfunctionJul 22, 2025Break; Break
IT WAS REPORTED THAT DURING THE PROCEDURE THE EXTRACTION KIT OF THE RIA SYSTEM IS PASSED, THE PROPER CONNECTIONS WERE MADE TO PASS THE REAMER AND AT THE TIME OF RHYMING THE MEDULLARY CHANNEL IT WAS NOTICED THAT THE YELLOW SEAL, THE ONE THAT IS RESPONSIBLE FOR NOT LEAVING THE WATER, WAS MELTING. THE SPECIALIST WAS INFORMED TO STOP SO IT COULD BE CHANGED. IT WAS THEN NOTICED THAT THE BLUE PLASTIC WAS ALSO MELTING. FOR THIS NOVELTY THERE WAS NO DISCOMFORT ON THE PART OF THE DOCTOR. THE DOCTOR REPORTS THAT HE KNEW THAT THE RIA SYSTEM WAS NOT INDICATED FOR THIS PROCEDURE BUT THAT HE NEEDED IT TO COLLECT THE PATHOLOGY. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563741 ↗MalfunctionJul 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT AN INCIDENT OCCURRED DURING A GRAFT HARVESTING PROCEDURE VIA THE RIA2 SYSTEM. THE APPROACH PROCEDURE WAS PROPERLY FOLLOWED, WITH THE RIA INSERTED ALMOST IN THE AXIS OF THE FEMORAL SHAFT. THE PROBLEM OCCURRED DURING THE FIRST DRILLING WITH THE SMALLEST DIAMETER 10MM DRILL HEAD. THE DIAMETER OF THE BARREL WAS AT LEAST 10.5MM SO THERE WAS NO PROBLEM ACCESSING THE RIA. IT IS DURING THE REMOVAL OF THIS HEAD THE FINS BROKE INSIDE THE PATIENT, A SHORT DISTANCES FROM THE FEMORAL NECK, REQUIRING THE SURGEON TO USE LAPAROSCOPIC FORCEPS TO RECOVER THE PIECES. THE SURGERY WAS DELAYED BY ABOUT HALF AN HOUR. IT WAS ALSO NOTICED SHRINKAGE OF THE OUTER PLASTIC AT THE END OF THE RIA REQUIRING TO USE A SECOND RIA2. THE REST OF THE PROCEDURE WAS CONSISTENT WITH USAGE AND RECOVERED 60CC OF QUALITY GRAFT. THE PATIENT IS CURRENTLY DOING WELL; HOWEVER, HE REQUIRED 6 BLOOD BAGS DUE TO SIGNIFICANT PERIOPERATIVE BLEEDING. THERE HAS BEEN NO ADDITIONAL SURGICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED STATES THAT "DURING THE OPERATION (FILLING IN THE BONE CAVITY OF THE LEFT FEMORAL SHAFT), THE SURGEON USED EQUIPMENT TO LOAN THE RIA 2 KIT REQUESTED DURING THE PROGRAMMING OF THE PATIEN
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22506210 ↗MalfunctionMay 29, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025, THE SURGEON USED THE RIA 2 DEVICE AND IT WAS NOTED THAT THE PLASTIC MELTED AND IT WAS DIFFICULT TO REMOVE THE RIA SHAFT FROM THE PLASTIC RIA GRAFT KIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SUFFICIENT GRAFT. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22106060 ↗MalfunctionMay 9, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025 THE REAMER IRRIGATOR ASPIRATOR HEAD DISENGAGED FROM SHAFT AND INNER PIECES BROKE WITHIN THE FEMUR. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21997388 ↗MalfunctionApr 24, 2025Break; Device-Device Incompatibility; Difficult to Advance; Break; Device-Device Incompatibility; Difficult to Advance
DURING SURGERY THE RIA SYSTEM HOSE PRESENTS FAILURES SINCE THE TIP WHERE THE HOSE CONNECTS TO THE RAMER BREAKS CAUSING IT TO STOP WORKING PROPERLY, WHICH IS WHY IT IS NECESSARY TO UNCLOG ANOTHER RIA SYSTEM. IN ADDITION TO THIS, THE DOCTOR REPORTS THAT THE RIA HEADS WERE ADVANCING WITH GREAT DIFFICULTY THROUGH THE MEDULLARY CANAL, WHICH MAKES IT DIFFICULT TO TAKE THE GRAFT, IT SHOULD BE CLARIFIED THAT THE SYSTEM WAS MOUNTED CORRECTLY AND IT WAS CHECKED THAT EVERYTHING WAS WELL CONNECTED IN ADDITION TO DOING THE PREVIOUS STEPS OF THE TECHNIQUE BEFORE INTRODUCING THE RIA INTO THE MEDULLARY CANAL, AT THE END OF THE SURGERY THE DOCTOR INFORMS THAT ONLY ONE RIA KIT CAN BE CHARGED, ARGUING THAT THE ONE THAT PRESENTED THE NOVELTY IS A PRODUCT FAILURE AND THAT FOR THIS REASON THE DESIRED AMOUNT OF GRAFT COULD NOT BE EXTRACTED AND DOES NOT AUTHORIZE THE INCLUSION OF THE RIA SYSTEM KIT WITHIN THE EXPENSE, IN ADDITION TO THIS, THE HEAD OF THE STERILIZATION CENTER INDICATES THAT IT IS NOT THE FIRST TIME THAT THERE HAVE BEEN PROBLEMS WITH THIS SYSTEM. THE SURGERY WAS ULTIMATELY COMPLETED SUCCESSFULLY, WITHOUT ANY HARM TO THE PATIENT OR DISRUPTION TO THE SURGICAL TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899643 ↗MalfunctionNov 19, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE RIA2 BROKE WHILE BEING USED. THE INSTRUMENT WAS STERILE BOXED. THE SURGERY WAS NOT DELAYED, BUT THE INSTRUMENT WAS UNUSABLE.
Patient problems: Insufficient Information
MAUDE report 20725559 ↗MalfunctionNov 11, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO OTHER INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20659069 ↗MalfunctionOct 3, 2024Break; Break
IT WAS REPORTED THAT ON SEPTEMBER 27, 2024, THE RIA KIT BROKE DURING A CASE.
Patient problems: Insufficient Information
MAUDE report 20360867 ↗MalfunctionOct 3, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, DURING A TIBIA INFECTION WASHOUT, THE METAL PORTION OF THE RIA GUN HANDLE DISPOSABLE BROKE IN SEVERAL PIECES WHILE REAMING. THERE WAS 10 MINUTES SURGICAL DELAY. PROCESSED WITH SURGERY AND DID THE BEST FOR THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. THE METAL END OF DISPOSABLE BROKE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20360628 ↗MalfunctionJul 25, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE SEAL OF THE INSTRUMENT BROKE INTRAOPERATIVELY DUE TO EXTREME FLEXING OF THE SHAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE RIA 2 BONE HARVESTING KIT 520MM STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19826009 ↗MalfunctionJul 5, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT HARDWARE REMOVAL AFTER RIGHT HUMERUS NON-UNION. DURING THE PROCEDURE, BONE HARVEST CLOGGED INTO THE ASSEMBLY. THE RAI 2 SHAFT WAS STUCK INSIDE THE ASSEMBLY; THE PLASTIC WAS CUT AWAY FORM THE SHAFT. THIS REPORT IS FOR AN RAI 2 BONE HARVESTING KIT. THIS IS REPORT 3 OF 5 FOR (B)(4). (B)(4) CAPTURES THE INTRA-OPERATIVE RAI 2 ISSUES. RELATED COMPLAINT (B)(4) CAPTURES THE REQUIRED REVISION PROCEDURE DUE TO NON-UNION.
Patient problems: Insufficient Information
MAUDE report 19680332 ↗MalfunctionFeb 15, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024,, BLUE CLIPS BROKE OFF IN THE RIA 2 TUBE ASSEMBLY DURING SURGERY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. SURGERY WAS DELAYED BUT IT WAS UNKNOWN HOW LONG. THIS REPORT IS FOR ONE (1) RIA 2 BONE HARVESTING KIT 520MM STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18711530 ↗MalfunctionDec 8, 2023Break; Material Deformation; Break; Material Deformation
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED, DURING THE PROCEDURE ON NOVEMBER 16, 2023 (AUTO GRAFT COLLECTING FROM THE LEFT PROXIMAL FEMUR), THE TUBE ASSEMBLY MALFUNCTIONED AND TWISTED. IT APPEARS THE DRIVE SHAFT CAME DISCONNECTED, AND WHILE IT WAS SPINNING AT HIGH SPEEDS, IT TWISTED THE HOSE AND MELTED THE ROD SEAL. ANOTHER DRIVE SHAFT AND ASSEMBLY TUBE WAS REQUIRED TO FINISH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 20 MINUTE SURGICAL DELAY. THIS REPORT IS FOR RIA 2 BONE HARVESTING KIT 520MM STERILE FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18294750 ↗MalfunctionOct 31, 2023Break; Break
DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE, THE RIA 2 COUPLING WORE OUT. TWO SEPARATE RIA 2 REAMER HEADS WERE DAMAGED DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN RIA 2 BONE HARVESTING KIT 520MM STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18039476 ↗MalfunctionAug 14, 2023Break; Entrapment of Device; Break; Entrapment of Device
DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WITH POST-TRAUMA SCLEROSIS OF THE MIDDLE THIRD OF THEIR TIBIA UNDERWENT MILLING OF THE ENDOMEDULLARY CANAL FOR WASHING AND PATHOLOGY COLLECTION. A FEW MINUTES INTO THE PROCEDURE, THE SURGEON TOOK AN X-RAY TO VERIFY THE SITE OF THE MILLING CUTTER AND SAW SOMETHING ABNORMAL WITH THE SYSTEM. THEY DECIDED TO REMOVE THE WHOLE SYSTEM, THE DISTAL PART OF THE HOSE AND THE MILLING CUTTER REMAINED INSIDE OF THE MEDULLARY CHANNEL. THE SURGEON THEN REMOVED THE OLIVATE GUIDE, WHICH BROUGHT THE DISTAL PART OF THE HOSE AND THE MILLING CUTTER OUT OF THE CHANNEL. HOWEVER THE MILLING CUTTER DID NOT HAVE ITS ANCHOR LEGS. ANOTHER X-RAY WAS TAKEN AND THE ANCHOR LEGS WERE CONFIRMED TO STILL BE INSIDE OF THE MEDULLARY CANAL. THE SURGEON PERFORMED ASPIRATION WITH THE CANNULA IN AN ATTEMPT TO REMOVE THE ANCHOR LEGS, BUT ONLY TWO OF THE FOUR WERE ABLE TO BE EXTRACTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN RIA 2 BONE HARVESTING KIT 520MM STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17540465 ↗MalfunctionJun 26, 2023Mechanical Problem; Contamination /Decontamination Problem; Mechanical Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON (B)(6) 2023 DURING A STRYKER REVISION RETROGRADE NAIL CASE, SURGEON UTILIZED RIA2 TO COLLECT BONE GRAFT. DURING HARVESTING, THE TUBING BECAME CLOGGED WITH BONE GRAFT NOT ALLOWING GRAFT TO BE COLLECTED. THE TUBING WAS CUT AND CLOGGED BONE GRAFT REMOVED. ANOTHER RIA2 KIT WAS OPENED TO CONTINUE GRAFT COLLECTION. NO FURTHER CLOGS OCCURRED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES WAS THERE. THIS REPORT IS FOR ONE (1) RIA 2 BONE HARVESTING KIT 520MM STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17201161 ↗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 16988044 ↗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 16987461 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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