NA 03.404.018SRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886982273963), received between Jun 24, 2020 and Dec 1, 2025 — classified as 16 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 18, 2026.

Recalls naming this device

1. Nov 19, 2020Class IITerminated

   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-0573-2021 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THE REAMER TIP BROKE INTO PIECES WHILE USING THE RIA II INSTRUMENTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23684974 ↗
• MalfunctionSep 22, 2025Break

  DEPUY REAMER HEAD BROKE OFF WHILE DOCTOR WAS SIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23109646 ↗
• MalfunctionAug 12, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025 THE TINES ON RIA2 REAMER HEADS BROKE OFF IN THE IM CANAL TWICE DURING AN I&D FOR A TIBIA. A SECOND REAMER WAS OPENED TO FINISH, BUT THAT ALSO BROKE. STD FLEX REAMERS WERE USED TO FINISH THE CASE. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS GENERATION OF FRAGMENTS. ATTEMPTS WERE MADE TO REMOVE FRAGMENTS BUT FAILED. FRAGMENTS ARE STILL INSIDE THE PATIENT. ADDITIONAL X-RAYS WERE TAKEN DURING REMOVAL EFFORTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22789341 ↗
• MalfunctionOct 4, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN TRAUMA PROCEDURE ON (B)(6) 2024. THE CUSTOMER USED RIA 2. THE REAMER HEAD BROKE AND FOUR PIECES OF METAL WERE IN THE FEMUR. IT WAS HARD TO GET ALL FRAGMENTS BUT FINALLY THEY WERE ALL REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF THIRTY FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 11.0MM REAMER HEAD FOR RIA 2 STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20368468 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RETENTION CLIPS ON RIA 2 HEAD BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19828913 ↗
• MalfunctionJan 18, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 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 AN 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18536848 ↗
• 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 18536840 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT ON NOVEMBER 30, 2023 WHILE USING THE RIA 2 SYSTEM IN A TIBIA, THE ATTACHMENT PRONGS ON THE RIA 2 HEADS BROKE OFF DURING REAMING AND WERE LEFT BEHIND IN THE PROXIMAL PART OF THE TIBIA. THIS HAPPENED TO TWO RIA 2 HEADS (A 10.5 MM AND 11.0 MM). THE BROKEN ATTACHMENT PRONGS WERE ABLE TO BE RETRIEVED FROM THE TIBIA USING LAPAROSCOPIC INSTRUMENTS. THERE WAS A SURGICAL DELAY OF 60 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ALL FRAGMENTS REMOVED. THIS REPORT IS FOR 11.0MM REAMER HEAD FOR RIA 2 STERILE FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18384652 ↗
• 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 SYNTHESE 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 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 REAMER

  Patient problems: Foreign Body In Patient

  MAUDE report 16987635 ↗
• InjuryApr 18, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, RIA2 11MM REAMER HEAD BROKE WHILE REAMING THE PATIENT¿S FEMORAL SHAFT. REAMER HEAD WAS REMOVED WITH 2.5MM BALL NOSE REAMING WIRE. A FEW METAL SPLINTERS WERE LEFT INSIDE OF THE INTRAMEDULLARY CANAL. NO ACTION WAS TAKEN TO REMOVE THE METAL SPLINTERS AND THERE WAS NO DELAY TO SURGERY. CONCOMITANT DEVICE REPORTED: UNK - REAMING RODS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1), DRIVE SHAFT FOR RIA 2 520MM (PART: 03.404.035; LOT# UNKNOWN; QUANTITY: 1), RIA 2 BONE HARVESTING KIT 520MM STERILE (PART: 03.404.000S; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16763091 ↗
• InjuryApr 13, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING A FEMORAL REAMING PROCEDURE, AN RIA 2 KIT (BORE, IRRIGATION, SUCTION) WAS USED WITH BORING HEADS OF SIZES 10, 11, 13, AND 15.5MM. AFTER USING THE 10MM HEAD WITH NO ISSUES, THE 11MM HEAD BROKE DURING USE INSIDE OF THE FEMORAL SHAFT. PIECES OF BROKEN FINS WERE FOUND INTRAOSSEOUS, AND THE HEAD CAME LOOSE OF THE GRAFT KIT AND ENDED UP INTRAOSSEOUS AS WELL. BECAUSE OF THIS, THE PREPARED 13 AND 15.5MM HEADS COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 30 MINUTES, BUT NOT UNDER THE CONDITIONS INITIALLY PLANNED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16736401 ↗
• InjuryApr 12, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THE LEGS OF THE 11MM RIA REAMER HEAD THAT ATTACH THE REAMER TO THE SHAFT BROKE OFF WHILE REAMING. 3 OF THE LEGS WERE RECOVERED AND REMOVED FROM THE PATIENT, ONE (1) OF LEGS WAS KEPT IN THE PATIENT. NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 11.0MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16727331 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 THE NATIVE TIBIA WAS INFECTED TO USE THE RIA. THEY USED THREE DIFFERENT HEAD SIZES. ALL THREE HEAD SIZES WERE BROKE INSIDE THE BONE DURING USAGE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ONE HOUR SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659557 ↗
• InjuryFeb 14, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE SURGEON WAS TAKING A BONE GRAFT AND THE 12MM REAMER HEAD SHEARED OFF IN LESS TIME IN THE FEMUR AND IT WOULD RETRIEVE LAST 40-45 MINUTES EFFORT. THEN, A SMALLER REAMER WAS PASSED AND IT ALSO BROKE AND THE TIME OF THE REAMER 1HR RETRIEVE FROM THE FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT STATUS WAS REPORTED TO BE FINE. THE BROKEN FRAGMENTS FROM ONE OF THE BROKEN REAMER HEADS WAS RETAINED IN THE MID SHAFT OF THE LEFT FEMUR. APPROXIMATELY 30 MINUTES WAS SPENT REMOVING THE BROKEN FRAGMENTS FROM THE INITIAL 12MM RIA 2 REAMER HEAD, WHICH WERE WITHIN THE PROXIMAL LEFT FEMUR. THE SECOND RIA2 11MM REAMER HEAD WHICH BROKE WAS MID-SHAFT AND COULD NOT BE RETRIEVED EVEN THOUGH SEVERAL ATTEMPTS WERE MADE. THIS REPORT INVOLVES ONE 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16371178 ↗
• InjuryFeb 2, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THIS PATIENT WAS UNDERGOING A REVISION SURGERY OF THE TIBIA. THE ORIGINAL SURGERY WAS DONE BY ANOTHER SURGEON AND A NON SYNTHES PLATE AND SCREWS WERE USED. THE PATIENT DEVELOPED A NON UNION OF THE DISTAL TIBIA FROM THE ORIGINAL SURGERY. SURGEON REMOVED THE NON SYNTHES PLATE AND NON SYNTHES SCREWS IN ORDER TO ADDRESS THE TIBIAL NON UNION. ONCE THE HARDWARE WAS REMOVED DR. (B)(6) REDUCED THE NON UNION AND USED THE RIA 2 REAM OUT THE TIBIA BEFORE IMPLANTING A TIBIAL NAIL. AS HE STARTED USING THE RIA 2 IT WAS NOTICED THE THE BONE WAS VERY HARD AND TOOK A LOT OF FORCE TO ADVANCE THE REAMER HEAD. SURGEON ADVANCED AND RETRACTED THE REAMER SEVERAL TIMES AND THE ANGLE NEEDED TO REAM THE CANAL WAS MORE THAN NORMAL DUE TO THE PATIENT ALSO HAVING A TOTAL KNEE IMPLANT IN PLACE. AS THE REAMER HEAD ENTERED THE ISTHMUS IT WAS NOTICED THAT THE REAMER HEAD HAD COME OFF OF THE DRIVE SHAFT IN THE CANAL. THE REAMER HEAD WAS RETRIEVED USING THE BALL TIPPED REAMING ROD AND THE REAMING WAS COMPLETED USING THE STANDARD FLEXIBLE REAMER SET. IT WAS NOTICED UNDER XRAY THAT TWO SMALL METAL PIECES REMAINED IN THE CANAL AFTER REAMING. THE PIECES WERE NOT ATTEMPTED TO REMOVE A

  Patient problems: Foreign Body In Patient

  MAUDE report 16284388 ↗
• InjuryOct 6, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, THE RIA 2 BONE HARVESTING DEVICE WAS BEING USED IN AN ANTEGRADE FASHION IN THE PATIENT¿S FEMORAL SHAFT. WHEN THE SURGEON WAS REMOVING THE REAMER FROM THE PATIENT IT WAS NOTICED ON X-RAY THE 11MM RIA 2 REAMER HEAD HAD COME OFF THE REAMER SHAFT. THE REAMER HEAD WAS STILL ON THE 2.5MM BALL TIP WIRE, SO THE BALL TIP WAS REMOVED TO RECOVER THE REAMER HEAD FROM THE CANAL. HOWEVER, IT WAS DISCOVERED ON X-RAY THE TINES FROM THE REAMER HEAD HAD BROKEN OFF AND WERE LEFT IN THE FEMUR. THERE WAS AN EFFORT TO REMOVE THE PIECES, BUT THEY WERE ULTIMATELY LEFT IN THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH 10MIN OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15553616 ↗
• InjuryMay 25, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2022, DURING A PROCEDURE, THE SURGEON WAS REAMING THROUGH A PREVIOUSLY HEALED GUNSHOT OF THE FEMUR. THERE WERE MANY METAL BULLET FRAGMENTS THAT CAUSED VERY HARD CALLUSED BONE THE RIA 2 WAS REAMING THROUGH. FORCE WAS APPLIED TO THE REAMER HEAD ENTERING AND PULLING BACK. THE LEGS THAT HOLD THE REAMER HEAD IN THE RIA SHAFT BROKE AND THE HEAD DETACHED. THE MAIN PART OF THE REAMER HEAD REMAINED INTACT AND WAS RETRIEVED WITH THE BALL OF THE REAMING ROD. METAL FRAGMENTS FROM THE RIA HEAD LEGS BROKE OFF AND REMAINED IN THE PATIENT. THERE WAS A 12 MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14496332 ↗
• InjuryMar 11, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A SCHEDULED TRANSPLANT OPERATION BONE MARROW, THE PRACTITIONER USED AN RIA KIT 2 (BORING, IRRIGATION, SUCTION) IN FRAME MASKLET'S TECHNIQUE. DURING THE PROCEDURE THE FINS OF THE HEADS, BORE SIZES OF 10, 10.5, 11 AND 14 MM, BROKE IN THE DISTAL THIRD OF THE FEMUR DESPITE USE OF THE DEVICE IN ACCORDANCE WITH SUPPLIER'S RECOMMENDATIONS. THE 16 BROKEN FINS ENDED UP IN INTRAOSSEOUS. THE PRACTITIONER WAS ABLE TO REMOVE ABOUT HALF OF THE FINS OF THE BORING HEADS; HOWEVER, PARTS REMAIN IN THE FEMUR DESPITE NUMEROUS RECOVERY ATTEMPTS. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) REAMER. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13731955 ↗
• InjuryFeb 14, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PERFORMING A RIA, TWO OF THE 11MM REAMER HEADS BROKE AND FRAGMENTS OF THE SPLINES WERE RETAINED INSIDE OF THE PATIENT. THE TIBIA CANAL WAS VERY SMALL AND THE SURGEON COMMENTED THE BONE WAS VERY HARD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A (30) MINUTES OF SURGICAL DELAY. FRAGMENTS WERE GENERATED AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13523730 ↗
• InjuryFeb 14, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PERFORMING A RIA, TWO OF THE 11MM REAMER HEADS BROKE AND FRAGMENTS OF THE SPLINES WERE RETAINED INSIDE OF THE PATIENT. THE TIBIA CANAL WAS VERY SMALL AND THE SURGEON COMMENTED THE BONE WAS VERY HARD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY(30) MINUTES OF SURGICAL DELAY. FRAGMENTS WERE GENERATED AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13523707 ↗
• MalfunctionDec 15, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING INTRAMEDULLARY (IM) REAMING OF THE FEMUR, THE REAMER/IRRIGATOR/ASPIRATOR (RIA) 2 REAMER HEAD BROKE AT THE SHAFT JUNCTION. SURGEON REMOVED THE SHATTERED REAMER HEAD FROM THE FEMORAL CANAL. IT TOOK APPROXIMATELY THIRTY (30) MINUTES TO REMOVE ALL FRAGMENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 11.0MM 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 13011438 ↗
• 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 FIVE (5) MINUTES SURGICAL DELAY. THE PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12782390 ↗
• InjuryJul 15, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A FEMORAL PROCEDURE DUE TO OSTEOMYELITIS INFARCTION, ONE (1) 10.5MM REAMER HEAD AND ONE (1) 11.0MM REAMER HEAD TINES WERE BROKEN AND EMBEDDED IN THE PATIENT. ONE (1) DRIVE SHAFT WAS BROKEN DURING REAMING. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN REAMING ROD (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1), UNKNOWN DRILL BITS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12177039 ↗
• MalfunctionJul 7, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE REAMER HEAD FOR REAMER IRRIGATOR ASPIRATOR (RIA) 2 BROKE APART WHILE USE IN THE OPERATING ROOM. REAMER HEAD BROKE OFF 4 PIECES DURING THE SURGICAL CASE. ONE WAS FOUND IN THE PATIENT'S FEMUR CANAL ON X-RAY AFTER REMOVAL OF THE FEMORAL NAIL AND USE OF THE REAMER. TWO PIECES IN THE REAMER SHAFT FOLLOWING SUCTIONING, AND ONE PIECE WAS FOUND ON THE STERILE TABLE UPON COMPLETION OF THE CASE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN FEMORAL NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN REAMER SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128411 ↗
• InjuryMay 10, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING REMOVAL THE REAMER IRRIGATOR ASPIRATOR (RIA) 2 REAMER HEAD BROKE OFF DURING REAMING. THE REAMER WAS REMOVED AND FRAGMENTS NOT RETRIEVABLE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS (B)(4) CAPTURES THE INTRA-OP EVENT DURING REMOVAL, THE REAMER HEAD BROKE OFF. (B)(4) CAPTURES THE POSTOP EVENT, REMOVAL DUE TO NONUNION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11798039 ↗