NA 03.404.020SRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886982273987), received between May 5, 2020 and Oct 15, 2024 — classified as 10 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (28 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, 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-0575-2021 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RIA WAS BEING USED TO COLLECT AUTOGRAFT FROM A FEMORAL SHAFT WHEN THE RIA HEAD BROKE OFF INTO 4 PIECES INSIDE THE BONE. ALL OF THE PIECES WE RETRIEVED WITH LONG GRASPERS WITHOUT INCIDENT, AND THE OTHER DRIVE SHAFT WAS USED WITHOUT ANY FURTHER ISSUES. THE DRIVE SHAFT WAS FOUND TO BE DAMAGED AT THE TIP AND THE REAMER HEAD NEEDS TO BE REPLACED AS WELL. THERE WAS NO SURGICAL DELAY AND NO PATIENT STATUS/ OUTCOME OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456309 ↗
• MalfunctionMar 5, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE RIA 2 REAMER HEADS BROKE DURING THE REMOVAL PROCEDURE FROM THE FEMUR. FRAGMENTS WERE GENERATED. AN ATTEMPT WAS MADE TO REMOVE THE INDIVIDUAL COMPONENTS OF THE REAMER HEADS AND THE THREE COMPONENTS COULD NOT BE REMOVED FROM THE FEMUR. THERE WAS A THIRTY (30) MINUTE SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 18837495 ↗
• MalfunctionDec 26, 2023Break; Entrapment of Device; Break; Entrapment of Device

  AFTER INTERVENTION, THE PATIENT DID NOT RETAIN ANY BROKEN FRAGMENTS.

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

  MAUDE report 18392313 ↗
• MalfunctionNov 29, 2023Break; Break

  DEVICE REPORT FROM NEW ZEALAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE PRONGS OF THE REAMER HEAD IN QUESTION BROKE OFF WHILE BEING USED. WHILE USING RIA2 IN OSTEOMYLITIC FEMUR, THE PRONGS BROKE OFF INSIDE OF THE FEMUR, LEAVING TWO METAL PIECES BEHIND IN THE BONE. X-RAY WAS REQUIRED TO LOCATE THE FRAGMENTS, AND THEY ALL WERE REMOVED BY THE SURGEON AT THE TIME OF THE PROCEDURE. SURGERY WAS COMPLETED SUCCESSFULLY AFTER A DELAY OF 30 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT, THEY WERE REPORTED AS FOLLOWING THE NORMAL CLINICAL PATH. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 12.0MM 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 18232081 ↗
• MalfunctionOct 26, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE FEMUR BORING PROCEDURE, FOR CANCELLOUS TISSUE COLLECTION WITH RIA2 SYSTEM, 3 HEADS DISASSEMBLED FROM THE CRANKSHAFT AND BROKE. THIS REPORT INVOLVES ONE (1) 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information; Post Operative Wound Infection

  MAUDE report 18013868 ↗
• MalfunctionSep 11, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS PERFORMING AN ANTEGRADE RIA2 BONE-HARVESTING PROCEDURE. WHEN REMOVING THE RIA2 ASSEMBLY FROM THE PROXIMAL FEMUR, THE RIA2 HEAD BROKE AT THE JUNCTION OF THE 4 FLANGES AND THE CUTTING REAMER HEAD. AS THE REAMING ROD WAS REMOVED WITH THE CUTTING END OF THE RIA2 HEAD ATTACHED, THE DETACHED FLANGES BECAME IMPALED IN THE SURROUNDING SOFT TISSUES. THE SURGEON MADE SEVERAL ATTEMPTS TO RETRIEVE THE FRAGMENTS, HOWEVER AFTER 30+ MINUTES OF CONSISTENT EFFORT, DECIDED THAT MORE HARM WAS BEING DONE TO THE SOFT TISSUES AND HAD TO ABANDON THE RETRIEVAL EFFORTS. THE PRODUCT FAILURE RESULTED IN 4 FRAGMENTS, ROUGHLY 5MM X 2MM X 1MM LEFT WITHIN THE SOFT TISSUES OF THE PATIENT'S HIP ABDUCTORS. THE GRAFT HARVESTING PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17720605 ↗
• MalfunctionJun 28, 2023Break; Entrapment of Device; Break; Entrapment of Device

  THERE WAS MEDICAL INTERVENTION. LONG KERRISONS AND A TI NAIL EXTRACTION ROD WERE USED TO GRAB AND SCOOP OUT THE FRAGMENTS; ADDITIONAL SURGICAL TIME AND X-RAY USAGE WERE REQUIRED. FOR THE PATIENT'S STATUS, THERE WAS NO REPORTED ADVERSE OUTCOME.

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

  MAUDE report 17215689 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED, THAT DURING SURGERY ON (B)(6) 2023. THE RIA HEAD FAILED. THE PHALANGES THAT ARE ON THE SHAFT OF THE HEAD BROKE OFF. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. AND THERE WAS A DELAY OF 45 MINUTES IN RELATION TO THE EVENT. THE SURGEON WAS ABLE TO GRAB THE BROKEN PIECES OF THE CANAL, BUT IT WAS NOT EASY TO REMOVE THE FRAGMENTS. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT IS FOR ONE (1) 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151380 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED, THAT DURING SURGERY ON (B)(6) 2023. THE RIA HEAD FAILED. THE PHALANGES THAT ARE ON THE SHAFT OF THE HEAD BROKE OFF. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. AND THERE WAS A DELAY OF 45 MINUTES IN RELATION TO THE EVENT. THE SURGEON WAS ABLE TO GRAB THE BROKEN PIECES OF THE CANAL, BUT IT WAS NOT EASY TO REMOVE THE FRAGMENTS. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE 12.0MM 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 17151379 ↗
• MalfunctionMar 22, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  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) 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589788 ↗
• MalfunctionFeb 13, 2023Break; Break

  IT WAS REPORTED THAT ON AN (B)(6) 2023, DURING INTRA-OP, THE SALES REP REPORTED THAT THE EVENT WAS TAKING ON LESS REAMER (RIA 2) AND THE 12MM REAMER HEAD SHRED OFF IN LESS TIME IN THE FEMUR. THE EFFORT TO RETRIEVE WAS ABOUT 40-45MIN. A SMALLER REAMER WAS PASSED IT ALSO BROKE. THE REAMER TOOK 1HR TO RETRIEVE FROM THE FEMUR. PATIENT CONSEQUENCES ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS FOR ONE (1) 12.0MM 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 16368212 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, IN TWO CASES, THE REAMER HEAD SMACKED OFF AND BROKE. A REPLACEMENT INSTRUMENT WAS NEEDED TO COMPLETE THE PROCEDURE. THIS EVENT DID NOT DELAY THE CASE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595444 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 , IN TWO CASES, THE REAMER HEAD SMACKED OFF AND BROKE. A REPLACEMENT INSTRUMENT WAS NEEDED TO COMPLETE THE PROCEDURE. THIS EVENT DID NOT DELAY THE CASE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 4 OF 4 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595421 ↗
• InjurySep 9, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A REAMER HEAD THAT BROKE INSIDE THE PATIENT DURING A PROCEDURE. THERE WAS A SURGICAL DELAY FOR 5 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME: RETAINED PIECES OF RIA2 HEAD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 12.0MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15396851 ↗
• InjuryApr 29, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN ISRAEL THAT A PATIENT UNDERWENT A BONE GRAFT HARVEST PROCEDURE ON A FEMUR BONE ON (B)(6) 2022. ACCORDING TO THE REPORT, THE SURGEON STARTED PERFORMING THE PROCEDURE USING A 10 MM DIAMETER REAMER HEAD DEVICE CONNECTED TO A DRIVE SHAFT AS HE ENTERED A FEW CENTIMETERS INTO THE CANAL. IT WAS REPORTED THAT AS HE RETREATED BACK TO COLLECT THE BONE GRAFT, HE HEARD NOISES AND FELT VIBRATION IN THE DEVICE. IT WAS REPORTED THAT THE SURGEON STOPPED THE HARVEST PROCEDURE AND AN X-RAY WAS TAKEN SHOWING THAT THE REAMER HEAD WINGS BROKE AND DETACHED FROM THE REAMER HEAD WITH SHREDS OF METAL SCATTERED IN THE CANAL. IT WAS REPORTED THAT THE REAMER HEAD WAS REPLACED WITH A 10.5MM DIAMETER NEW REAMER HEAD TO CONTINUE THE PROCEDURE. IT WAS REPORTED THAT THE SURGEON RE-ENTERED THE CANAL SEVERAL CENTIMETERS DEEP AND WHEN HE RETREATED TO COLLECT THE BONE GRAFT HE HEARD NOISES AND FELT VIBRATION AGAIN. IT WAS REPORTED THAT THE REAMER HEAD WINGS DISCONNECTED FROM THE REAMER HEAD AGAIN AND ADDITIONAL METAL FRAGMENTS WERE SEEN IN THE CANAL X-RAY. IN ORDER TO COMPLETE T

  Patient problems: Foreign Body In Patient

  MAUDE report 14250874 ↗
• InjuryMar 18, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE ATTEMPTING TO PASS THE REAMER HEAD FOR REAMER / IRRIGATOR / ASPIRATOR (RIA) 2 BECAME DISLODGED AFTER THE SPLINES BROKE. THE REAMER WAS REMOVED AND THE SURGEON ASKED FOR A SMALLER ONE. FRAGMENTS OF THE RIA HEAD REMAINED IN THE FEMORAL CANAL. THERE WERE TEN MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES (1) 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13804673 ↗
• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE REAMER HEADS FOR REAMER IRRIGATOR ASPIRATOR (RIA) 2 BROKE OFF WHILE HARVESTING BONE GRAFT FROM THE LEFT FEMUR. X-RAY CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 12.0MM 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 13509542 ↗
• InjuryFeb 2, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE COLLECTION OF BONE FROM THE RIGHT FEMUR, FOR USE AROUND A RETROGRADE FEMORAL NAIL ON THE LEFT SIDE, SEVERAL ISSUES OCCURRED WITH THE RIA 2 DEVICE. EXCESSIVE HEATING OF THE HANDLE SURROUNDING THE MOTOR SHAFT OCCURRED WHICH CAUSED MELTING OF THE MATERIALS AND THE YELLOW SEAL. THE HEADS USED BROKE SUCCESSIVELY. THE METAL RING LOCATED AT THE END OF THE 2ND SHAFT GUIDE TORE. A DRILL CHUCK (BLUE COLOR) WAS USED ON THE MOTOR. THE INFORMED SURGEON TOOK CARE TO REMAIN AT AN ANGLE OF LESS THAN 10° WHEN INTRODUCING THE DEVICE. IRRIGATION OF THE DEVICE WAS SCRUPULOUSLY CONTROLLED THROUGHOUT THE OPERATION. THE FOLLOWING CONSEQUENCE OCCURRED: METALLIC RESIDUES POTENTIALLY REMAINED IN PLACE, THERE WAS SIGNIFICANT SURGICAL DELAY, AND THE AMOUNT OF BONE COLLECTED WAS NOT AS LARGE AS INITIALLY EXPECTED. THIS REPORT INVOLVES ONE (1) 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13423387 ↗
• MalfunctionJan 4, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE REAMER HEAD WAS BROKEN INTO FOUR PIECES INSIDE THE PATIENT'S TIBIA. ALL THE PIECES OF METAL ARE RETRIEVED. THERE WAS A 1.5-HOUR SURGICAL DELAY. THE PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: RIA 2 BONE HARVESTING KIT (PART# 03.404.000S, LOT# 321P622, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13157756 ↗
• InjuryDec 30, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A RIA2 PROCEDURE, THE REAMER HEAD CAME OFF THE SHAFT AND LEFT METAL PIECES INSIDE THE PATIENT. WHEN THE RAI WAS REMOVED, IT WAS NOTICED THE REAMER HEAD WAS NOT ATTACHED. AN INTRA-OPERATIVE X-RAY SHOWED THE REAMER HEAD WAS STILL IN THE TIBIA. THE REAMING ROD WAS PULLED OUT; IT HAD THE REAMER HEAD ON IT. ANOTHER X-RAY VERIFIED THERE WERE FOUR (4) SMALL METAL FRAGMENTS INSIDE THE PATIENT'S RIGHT TIBIAL CANAL. THOSE REMAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE (5) MINUTE DELAY. THIS REPORT IS FOR A RAI 2 REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13118928 ↗
• MalfunctionNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, WHILE REAMING, THE REAMER IRRIGATOR ASPIRATOR (RIA) 2 REAMING TIP DISCONNECTED AND LODGE IN THE DISTAL TIBIA. IT WAS EASILY REMOVED WITHOUT ANY OTHER INTERVENTION AND NO ADVERSE EVENTS OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 12.0MM 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 12747100 ↗
• InjurySep 1, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, THE REAMER IRRIGATOR ASPIRATOR (RIA) II HARVESTING KIT WAS INVOLVED WITH AN ALLEGATION. THE SALE CONSULTANT ADDED THE REAMER HEAD BROKE OFF PORTION DURING SURGERY AND THREE METAL SPLINES BROKE OFF IN THE PATIENT AS WELL. SPLINES WOULD NEED TO BE REMOVED, WHICH CAUSE THE FAILURE. THIS REPORT IS FOR ONE (1) 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12407727 ↗
• InjuryApr 9, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE FOR UNKNOWN REASON. BROKEN RIA 2 HEADS. REMOVED REAMING ROD WITH BROKEN HEAD, FRAGMENTS WERE GENERATED AND UNSUCCESSFULLY TRIED TO RETRIEVE WITH LAPAROSCOPIC GRASPER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SURGICAL DELAY OF 15 TO 20 MINUTES. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN REAMING ROD (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). DRIVE SHAFT FOR RIA 2 (PART# 03.404.035; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11645904 ↗
• InjuryDec 22, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING A BILATERAL FEMUR CASE THE REAMER HEAD FOR THE REAMER IRRIGATOR ASPIRATOR (RIA 2) BROKE WHILE REAMING. THE REAMER PRONGS BROKE WHILE REAMING THE SECOND LEG. THERE WERE RETAINED FRAGMENTS IN THE LESSER TROCH AREA. THE BROKEN REAMER WAS PULLED OUT USING THE BALL TIP GUIDE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A MINIMAL SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11055508 ↗
• MalfunctionDec 21, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT REVISION SURGERY DUE TO NON-UNION OF SMITH & NEPHEW TAYLOR-SPATIAL-FRAME. THE SURGEON USED THE RIA2 ASSEMBLY AND INSERTED WITH A REAMER HEAD. WHEN THE REAMER REACHED THE MEDIAL WALL, A SMALL AMOUNT OF ADVANCEMENT WAS ACHIEVED, BUT THE REAMER HEAD LEVERED AGAINST THE BONE AND BROKE. THE RIA2 ASSEMBLY WAS REMOVED AND BONE COLLECTION WAS ASSESSED. THE SURGEON NEEDED MORE GRAFT AND A SMALLER REAMER HEAD WAS SELECTED. THE RIA2 ASSEMBLY WAS ONCE AGAIN INSERTED. FURTHER PROGRESS WAS MADE BEYOND THE INITIAL REAMER PATH. ONCE AGAIN, WHEN THE REAMER REACHED THE MEDIAL WALL, A SMALL AMOUNT OF ADVANCEMENT WAS ACHIEVED, BUT THE REAMER HEAD LEVERED AGAINST THE BONE AND BROKE. THE RIA2 ASSEMBLY WAS REMOVED AND BONE COLLECTION WAS ASSESSED WITH A SATISFACTORY VOLUME COLLECTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIFTEEN TO TWENTY (15-20) MINUTE SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: RIA 2 BONE HARVESTING KIT (PART#: 03.404.000S, LOT#: 76P1726, QUANTITY: 1); REAMING ROD WITH BALL TIP (PART#: 351.706S, LOT#: 58P3889, QUANTITY: 1). THIS REPORT IS FOR 1 12.0MM REAMER HEAD FOR RIA 2 STERILE. THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11048223 ↗