NA 03.404.016SRecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10886982273932), received between May 7, 2020 and Feb 6, 2026 — classified as 22 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (50 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 19, 2020Terminated

   RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

   Z-0571-2021 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Break; Entrapment of Device

  THE REAMER HEAD WITH A DIAMETER OF 10.0MM FRACTURED DISTALLY DURING THE SURGICAL PROCEDURE AND REMAINED IN THE FEMORAL CANAL. ATTEMPTS WERE MADE TO RETRIEVE THE FRAGMENTS BUT WERE UNSUCCESSFUL. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN MINUTE DELAY.

  Patient problems: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278017 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, WHILE REAMING THE FEMUR WITH RIA 2, THE HEAD BROKE OFF INTO PIECES WITHIN THE FEMUR. ADDITIONAL X-RAY WAS REQUIRED TO REMOVE THE PIECES WITH A LAPAROSCOPIC NEEDLE DRIVER. ALL PIECES WERE REMOVED. A 45 MINUTE DELAY OCCURRED DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533335 ↗
• MalfunctionMay 12, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE SPINES OF THE RIA TWO HEADS THAT ATTACH TO THE REAMER SHAFT SEPARATED FROM THE REAMER HEAD. THEY WERE STILL IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22002818 ↗
• MalfunctionApr 30, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE RIA 2 REAMER HEAD BROKE OFF, AND THE SURGEON DECIDED TO LEAVE THEM. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. FRAGMENT GENERATED. THE PATIENT CONSEQUENCES WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21936794 ↗
• MalfunctionMar 3, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE RIA 2 HEAD BROKE DURING REAMING AND THE DRIVE SHAFT COULD ALSO BE BROKEN. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOMES.

  Patient problems: Insufficient Information

  MAUDE report 21503311 ↗
• MalfunctionJul 17, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING A TIBIAL NAIL PROCEDURE ON (B)(6) 2024, DURING REAMING, THE CLIPS ON REAMER BROKE WERE LEFT IN BONE. DURING THE CASE THE TINT ON REAMER HEAD PART BROKE OFF IN THE PATIENT. A SURGICAL DELAY OF 15 MINUTES OCCURRED DUE TO TRYING TO REMOVE THE FRAGMENTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BUT 3 TINES OF THE REAMER HEAD WERE LEFT IN THE MEDULLARY CANAL OF THE TIBIA. THIS REPORT IS FOR ONE 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19761355 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DUE TO PATIENT ANATOMY THE KNEE CANNOT BE FLEXED AS NEEDED SO THERE WAS SOME BEND ON THE REAMER SHAFT. THERE MAY HAVE BEEN A LITTLE TO MUCH FORCED ON THE REAMERS SHAFT AND HEAD AS THEY WHERE PUSHED DOWN THE TIBIAL CANAL. THE TINES OF REAMER HEAD BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY AND NO PATIENT OUTCOME. THIS REPORT IS FOR ONE 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932707 ↗
• MalfunctionJan 24, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON 08-DECEMBER-2023, THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT OF THE TIBIA, THERE WAS A REMOVAL OF HARDWARE AND ANTIBIOTIC NAIL. DURING THE PROCEDURE WHILE USING THE RIS BONE HARVESTING KIT IT WAS NOTICED THAT SMALL PIECES OF THE REAMER HEADS WERE BREAKING OFF IN THE INTERMEDULLARY CANAL OF THE PATIENT'S LEFT TIBIA. ATTEMPTS WERE MADE TO REMOVE THE FRAGMENTS UNDER C-ARM. SEVERAL SMALL FRAGMENTS WERE VISIBLE AT THE ANKLE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18576748 ↗
• MalfunctionJan 18, 2024Break; Entrapment of Device; Break; Entrapment of Device

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4), A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18536841 ↗
• 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 A 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540462 ↗
• MalfunctionAug 9, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW ZEALAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE RIA 2 HEAD BROKE DURING THE CASE, IN MIDSHAFT TIBIA. ALL FOUR LEGS OF THE CONNECTION POINT BROKE AND HAD TO BE RETRIEVED. THE DRILL WAS ON THE RIGHT DRILL SETTING, AND SURGEON USED THIS VERY CONSISTENTLY. THERE WAS A SURGICAL DELAY. THE FRAGMENTS WERE REMOVED WITH PITUITARIES. NOT ALL FRAGMENTS WERE ABLE TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491627 ↗
• InjuryJun 5, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2023, WHILE USING RIA2 TO HARVEST BONE FROM THE CONTRALATERAL FEMUR FOR A FEMORAL NON-UNION THE 10MM REAMER HEAD BROKE INTO 5 PIECES WITHIN THE FEMORAL CANAL. WE WERE ABLE TO HARVEST A LOT OF BONE BUT THIS ADDED SIGNIFICANT TIME TO THE CASE DUE TO A DILIGENT EFFORT TO FISH OUT THE METAL SHARDS. WE HAD OUR LARGE POWER SET AT DRILL SPEED AND EVERYTHING WAS ASSEMBLED PROPERLY. UNFORTUNATELY THIS HAS HAPPENED BEFORE TO THE SAME SURGEON AND THERE MUST BE SOMETHING WRONG WITH THE DRIVE SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 120 MINUTES. THIS REPORT IS FOR ONE (1) 10.0MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17061525 ↗
• MalfunctionJun 1, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS ATTEMPTING TO USE THE RIA THROUGH A NON UNION SITE. THE SPLINES ON THE 10MM REAMER HAD BROKE, LEAVING SEVERAL FRAGMENTS IN THE CANAL OF THE FEMUR. THE SURGEON WORKED TO ENSURE HE REMOVED ALL OF THE FRAGMENTS FROM THE REAMER HEAD. THE SURGEON THEN MADE AN ANTIBIOTIC NAIL USING A 3.0 REAMING ROD, CEMENT AND TEMPORARILY IMPLANTED IT IN THE FEMUR. THERE WAS 20 MIN SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - NAILS(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: UNKNOWN). UNK - REAMING RODS: TRAUMA(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: UNKNOWN). UNK - BIOMATERIAL - CEMENT(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). THIS COMPLAINT INVOLVES ONE(1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042250 ↗
• 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 16987536 ↗
• InjuryMay 2, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A RIA2 PROCEDURE, THE REAMER HEAD DECOUPLED FROM THE FLANGES, RESULTING IN FOUR FREE FLANGE FRAGMENTS INSIDE THE PATIENT CANAL. AS A RESULT OF THE FLANGES BREAKING FREE, THE DISPOSABLE RIA SHAFT WAS DAMAGED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16852904 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT THE BROKEN FRAGMENTS WERE RETRIEVED AND NOT LEFT IN THE PATIENT. SUCTION AND GRASPERS WERE USED TO RETRIEVE. THE SURGERY WAS COMPLETED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659527 ↗
• MalfunctionMar 22, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON UNKNOWN DATE WHILE PERFORMING A RIA, THE SURGEON NOTICED THAT HE WAS AGGRESSIVELY REAMING THE MEDIAL CORTEX OF THE FEMUR. HE STOPPED 1/3 OF THE DISTANCE OF THE FEMUR WITH A 12MM REAMER HEAD AND THEN WENT DOWN TO A 10MM RIA HEAD AND ENCOUNTERED THE RESISTANCE. THE SURGEON WAS CONCERNED THAT HE WAS TOO AGGRESSIVE WITH THE REAMER SIZE, HOWEVER WE MEASURED 14MM ON THE RULER AND STARTED WITH A 12MM. THE SURGEON CONSULTED OTHER SURGEONS AS TO WHETHER OR NOT HE SHOULD PROPHYLACTICALLY NAIL THE FEMUR, HOWEVER HE DECIDED NOT TO SINCE HE WAS GOING TO NOT LET THE PATIENT BARE WEIGHT FOR 3 MONTHS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 10.0MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589816 ↗
• MalfunctionMar 2, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE SURGEON WAS USING 10MM RIA2 HEAD IN METAPHYSEAL REGION OF TIBIA. THE REAMER WASN'T ADVANCING SO THEY TOOK AN X RAY AND NOTICED THE REAMER HEAD LOOKED MISALIGNED WITH THE REAMER SHAFT. THE REAMER WAS REMOVED FROM THE PATIENT AND IT WAS BROKEN AT THE LEGS OF IT. ALL THE PIECES WERE REMOVED AND WE USED ANOTHER 10MM HEAD WITH NO ISSUES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TEN(10) MINUTES OF SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16467827 ↗
• MalfunctionMar 1, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2023, A TIBIAL OSTEOTOMY WITH IM NAILING PROCEDURE WAS CONDUCTED. A 10MM RIA 2 HEAD WAS USED TO COLLECT GRAFT FROM THE TIBIAL CANAL. WHEN THE SURGERY WAS ALMOST DONE, IT WAS OBSERVED THAT THE BLUE RING ON THE BACK OF THE STERILE SHAFT TUB POPPED OUT AND APPEARED DAMAGED. IT'S ALMOST LIKE IT MELTED INTO THE METAL SHAFT. THE YELLOW SEAL WAS ALSO DAMAGED AND MELTED INTO THE SHAFT. THERE WAS A SURGICAL DELAY OF 3 MINUTES AND A POSITIVE SURGICAL OUTCOME WAS ATTAINED. PLASTIC FRAGMENTS WERE GENERATED THAT HAD TO BE PICKED OUT OF THE BONE GRAFT COLLECTED. NO FRAGMENTS REMAINED IN THE PATIENT. PATIENT STATUS/ OUTCOME: SUCCESSFUL THIS REPORT IS FOR ONE (1) 10.0MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460827 ↗
• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS A PROBLEM WITH THE DRIVE SHAFT FOR RIA2 AND THE 10MM RIA HEAD FOR RIA2. WHILE REAMING THE PATIENT¿S TIBIA, BOTH THE RIA HEAD CONNECTOR TO THE SHAFT SNAPPED AND BROKE OFF INTO THE PATIENT ONCE THE SHAFT WAS HIT TO THE TIBIA. THE CONNECTING PIECE OF THE RIA HEAD 2 WAS SNAPPED OFF INTO THE BONE AND BROKE AWAY FROM THE DRIVE SHAFT OF THE RIA2 DRIVER SHAFT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16073029 ↗
• MalfunctionDec 14, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A HARVESTING KIT WITH RIA ATTACHMENT SHAFT BROKE WHEN TRYING TO REMOVE FROM INSIDE THE TIBIA. THE REAMER HEAD ON THE RIA SHAFT WAS THE 10.0MM REAMER HEAD FOR RIA 2 STERILE. THE PARTS WITH ARTICULAR SHAFT PIECES BROKE, AND ALL PARTS WERE RETRIEVED. THE ASSOCIATED PIECES WERE THE SUPRAPATELLAR DRILL GUIDE (03.010.425), HANDLE (03.010.430), AND OUTER PROTECTION SLEEVE (03.010.437). THIS HANDLE WAS TEND TO BE REAMER (357.399) AS IN THE TECHNIQUE GUIDE; THIS T SHAFT WAS MENTIONED TO BE BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 6 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980032 ↗
• MalfunctionNov 28, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE RIA2 HEAD BROKE. A TROCHANTERIC START POINT WAS USED, APPROXIMATELY 6MM FROM THE TIP OF THE GREATER TROCHANTER, AND THE SURGEON ANGLED THE START WIRE TOWARDS THE LESSER TROCHANTER. THE SURGEON STRAIGHTENED THE DRILL BIT TO BE MORE IN LINE WITH THE FEMORAL CANAL, AND THE RIA2 HEAD BROKE APPROXIMATELY 2MM DISTAL OF THE LESSOR TROCHANTER. ALL METAL FRAGMENTS WERE RETRIEVED. THE EVENT CAUSED A SURGICAL DELAY OF 40 MINUTES, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868536 ↗
• InjuryOct 6, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE USING THE RIA2 ON AN INFECTED TIBIA THE REAMER HEAD BROKE OFF. THIS OCCURRED INSIDE OF THE PATIENT AND LEFT THREE FRAGMENTS INSIDE OF THE TIBIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15550741 ↗
• MalfunctionSep 1, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, TINY METAL DEBRIS STRIPPED OFF THE REAMER HEAD INTO PATIENT. SURGICAL DELAY UNKNOWN. PATIENT CONSEQUENCE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15337026 ↗
• InjuryJun 29, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THAT DURING BONE HARVESTING PROCEDURE OF THE RIGHT FEMUR, PART OF TWO RIA REAMER HEADS BROKE. NEW RIA2 REAMER HEADS WERE OPENED AND USED TO COMPLETE THE PROCEDURE. FRAGMENTS OF THE RIA2 REAMER HEAD WERE LEFT IN THE PATIENT, ADDITIONAL X-RAYS REQUIRED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 10.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14860253 ↗