NA 03.404.021SRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982274007), received between Sep 15, 2020 and Dec 4, 2025 — classified as 9 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (19 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. How this data works · Data updated Oct 13, 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-0576-2021 · Root cause: Use error · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT WHILE DOING A RIA2 CASE THE REAMER BROKE AND LEFT FRAGMENTS IN A PATIENTS FEMUR. SURGEON WAS ABLE TO REMOVE A MAJORITY OF THE INSTRUMENT BY PULLING THE BALL TIP GUIDE WIRE OUT BUT SOME FRAGMENTS OF IT WERE UNABLE TO BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23714901 ↗
• MalfunctionSep 3, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE RIA2 REAMER HEAD SHEARED OFF FROM THE RIA2 SHAFT WHILE ADVANCING IN THE IM CANAL NEAR THE ISTHMUS IN THE DISTAL PORTION OF THE PROXIMAL THIRD OF THE LEFT TIBIA. THE LOCKING PINS OF THE REAMER HEAD WERE LEFT IN THE PATIENT. IT WAS NOTED THE SURGEON WAS NOT BEING OVERLY AGGRESSIVE WHILE DRILLING AND THAT THE NON-DEPUY SYNTHES DRILL WAS SET TO ¿DRILL¿ NOT ¿REAM.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 22955792 ↗
• MalfunctionMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE MILLING HEAD WAS DISASSEMBLED. THIS RESULTED IN THE TEMPORARY INTERRUPTION OF THE PROCEDURE. THE SURGEON PROCEEDED TO RECOVER THE PIECE AND THE PROCEDURE RESUMED WITHOUT INCONVENIENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21608287 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RIA 2 12.5 REAMER HEAD TINES BROKE WHILE REAMING TIBIA CANAL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20784835 ↗
• 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) 12.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19828941 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REVISION TFNA PROCEDURE, THE HYBRID HANDLE WAS USED TO ATTACH THE TFNA, BUT IT WAS NOT PROPERTY CONNECTED. DURING INSERTION THE NOTCH BENT AND THE TFNA NAIL WAS WASTED. A NEW INSERTION HANDLE AND A BIGGER DIAMETER NAIL WAS USED. DURING REAMING A 10.5 REAMER HEAD WAS USED AND BROKE INTRA-OP, RIA 2 WAS THEN USED AND THEN THE 12.5 WAS USED BUT COULD NOT SNAP OFF REAMER HEAD OFF SHAFT. THERE WAS 5 MINUTES SURGERY DELAYED DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE 12.5MM REAMER HEAD FOR RIA 2 STERILE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842181 ↗
• MalfunctionOct 26, 2023Break; Break

  THERE WAS PROLONGED SURGICAL TIME. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME: FEMORAL SURGICAL WOUND INFECTION.

  Patient problems: Insufficient Information; Post Operative Wound Infection

  MAUDE report 18013992 ↗
• MalfunctionAug 4, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A RIA2 PROCEDURE ON (B)(6) 2023, THE 12.5MM REAMER HEAD BROKE OFF INSIDE THE TIBIAL CANAL. THE BALL TIP GUIDE WIRE IN USE HAD A BEND DISTALLY (SLIGHTLY KINKED), AND THE REAMER HEAD MADE IT OVER THE BENT AREA OF THE WIRE AS IT WAS ADVANCING, BUT WHEN IT WAS COMING OUT, IT BROKE OFF ONCE IT CLEARED THE AREA THAT WAS BENT. THE SURGERY WAS DELAYED BY 20 MINUTES, AND THE BROKEN REAMER HEAD AND FRAGMENTS WERE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. NO OTHER MEDICAL INTERVENTION WAS NECESSARY. THIS REPORT INVOLVES ONE 12.5MM 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 17457935 ↗
• MalfunctionAug 2, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE RIA 2 WAS USED TO COLLECT BONE GRAFT FROM THE LEFT FEMUR. THE REAMER HEAD WAS RETRIEVED AND NOTED TO BE BROKEN. THE CONNECTION POINT OF THE REAMER HEAD AND RIA SHAFT WERE BROKEN OFF. THE 2ND RIA SHAFT WAS THEN USED WITH A NEW REAMER HEAD AND GRAFT KIT AND THE PROCEDURE WAS COMPLETED. HOWEVER THE 2ND RIA SHAFT WAS ALSO BROKEN AND STUCK INSIDE OF THE BONE HARVESTING KIT. BOTH REAMER SHAFTS ARE DEEMED BROKEN AND NEW DISPOSABLES WERE OPENED. PROCEDURE COMPLETED SUCCESSFULLY WITH A THIRTY(30) MINUTES OF SURGICAL DELAY AND THE METAL SHAVINGS WERE LEFT IN FEMORAL CANAL. THIS REPORT IS FOR ONE (1) 12.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17445544 ↗
• MalfunctionFeb 27, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN HONG KONG AS FOLLOWS: IT WAS REPORTED THAT ON FEBRUARY 7 2023, DURING A TIBIA NON-UNION CASE IN QUEEN ELIZABETH HOSPITAL. SURGEON USE RIA2 WITH A 12.5 DIAMETER REAMER HEAD FOR HARVESTING BONE GRAFT IN THE FEMUR. PROPER ASSEMBLY FOR THE RIA2 WAS OBSERVED, THE REAMING WAS PERFORMED BY A COLLIBRI DRIVER WITH THE JACOB CHUCK ATTACHMENT 532.014. AFTER AROUND 3 MINS OF USAGE, THE REAMER HEAD WAS FOUND DETACHED, AND THERE WAS SOME METAL DEBRIS OBSERVED IN THE FEMUR CANAL. THE RIA2 WAS TAKEN OUT AND FOUND THAT THE LEG OF THE REAMER HEAD WAS BROKEN. THE SURGERY WAS DELAYED FOR 30 MINUTES. THE DEBRIS WAS EXTRACTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 12.5MM 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 16446061 ↗
• InjuryNov 2, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, 12.5MM RIA2 REAMER HEAD BROKE AT ATTACHMENT POINT LEAVING THE TIP IN THE BONE OF PATIENT, DETACHING IT FROM THE DRIVE SHAFT. HEAD WAS REMOVED WITH BALL TIP GUIDE WIRE AND NO HARM WAS CAUSED TO THE PATIENT. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE 12.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15715989 ↗
• InjurySep 28, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS PERFORMING A LEFT TIBIA HARDWARE REMOVAL OF AN INTRAMEDULLARY NAIL THAT WAS IMPLANTED AT ANOTHER FACILITY (NO DETAILS ARE AVAILABLE) AND DEROTATIONAL OSTEOTOMY WITH INSERTION OF A NEW INTRAMEDULLARY NAIL. THIS WAS DONE FOR NON-UNION REPAIR, AND FOR HARVESTING AND IMPLANTATION OF AUTOGRAFT USING THE "RIA 2" FROM THE SAME LEFT TIBIA AND FIBULAR OSTEOTOMY. AFTER THE HARDWARE REMOVAL, THE USE OF THE 12.5MM REAMER HEAD, BONE GRAFT HARVESTING KIT, AND DRIVE SHAFT FOR RIA 2, LENGTH 520 MM WERE USED TO COLLECT AUTOGRAFT FROM THE SAME TIBIA. WHILE REAMING/GRAFT COLLECTION, USING FLUOROSCOPY, IT WAS NOTICED THAT THE REAMER HEAD HAD DISCONNECTED FROM THE RIA 2 DRIVE SHAFT AND BONE GRAFT HARVESTING KIT. THE ENTIRE DEVICE WAS REMOVED IMMEDIATELY FOR FURTHER INSPECTION. UPON INSPECTION, IT WAS REALIZED AT SOME POINT DURING REAMING, THE 4 PRONGS ON THE REAMER HEAD THAT CONNECT TO THE REST OF THE DEVICE HAD BROKEN AND REMAINED IN THE INTRAMEDULLARY CANAL OF THE PATIENT. THE SURGEON DECIDED NOT TO RETRIEVE THE INSTRUMENT FRAGMENTS. THERE WERE 4 SMALL METAL PIECES THAT REMAINED. SIZE OF THE METAL FRAGMENTS IS ESTIMATED TO BE ABOUT 1MM X 4MM EACH.

  Patient problems: Foreign Body In Patient

  MAUDE report 15500787 ↗
• MalfunctionSep 2, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THAT THE SURGEON WAS EXPLANTING A TIBIAL NAIL EX AND IMPLANTING AN ANTIBIOTIC NAIL. THE PATIENT HAD AN INFECTION AND THE SURGEON WAS USING RIA 2 PRIOR TO INSERTING THE ANTIBIOTIC NAIL. WHILE USING THE RIA 2, IT WAS NOTICED UNDER FLUOROSCOPY THAT THE REAMER HEAD DETACHED FROM THE TUBE. AFTER REMOVING THE RIA TUBE AND THE BALL TIP GUIDE WIRE, IT BECAME APPARENT THAT 4 SMALL METAL PIECES WERE LEFT IN THE PATIENT'S CANAL. SURGEON REMOVED THE PIECES FROM THE CANAL AND UPON FURTHER INSPECTION, THE PIECES WERE FROM THE REAMER HEAD. AFTER REMOVAL OF THE METAL PIECES, THE SURGEON WAS ABLE TO COMPLETE THE CASE WITHOUT FURTHER COMPLICATIONS. THE SURGEON WAS ABLE TO USE VARIOUS INSTRUMENTS TO REMOVE THE METAL FRAGMENTS. THERE WAS A SURGICAL DELAY OF 45 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - NAILS: EXPERT TIBIAL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) UNK - GUIDE/COMPRESSION/K-WIRES (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR ONE (1) 12.5MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 15347867 ↗
• InjuryAug 29, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2022, THAT THE RIA 2 BONE HARVESTING KIT AND RIA 2 12.5MM REAMER HEAD BROKE AT THE JUNCTION OF THE DRIVE SHAFT AND REAMER HEAD. IT BROKE AND THEN CAME DETACHED FROM THE DRIVE SHAFT. THIS RESULTED IN METAL FRAGMENTS LEFT INSIDE THE FEMUR. THERE WAS A SURGICAL DELAY OF 10 MINUTES WHILE RETRIEVING THE METAL FRAGMENTS. THE SURGEON SIZED THE FEMORAL CANAL AT 11 AND THEN CHOSE A 12.5MM REAMER HEAD. WHEN THE SURGEON INSERTED THE RIA 2 INSIDE THE FEMUR AND BEGAN TO HARVEST GRAFT THE REAMER HEAD THEN BROKE FROM THE RIA 2 SHAFT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE CONSEQUENCES. THIS REPORT IS FOR ONE (1) 12.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15316340 ↗
• InjuryJun 30, 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 ONE (1) 12.5MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14874038 ↗
• InjuryJun 22, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SURGERY INSERTION OF A RIA 2 HEAD, THE HEAD BECAME DISLODGED FROM THE RIA SHAFT AND BROKE. FRAGMENTS WERE GENERATED AND SURGEON IS ABLE TO RETRIEVE THE HEAD OUT OF THE CANAL WITH THE 2.5MM BALL TIP GUIDE ROD. SOME OF THE FRAGMENTS CAME OUT BUT THERE WAS NO WAY TO GET THE OTHER FRAGMENTS AND THEY WERE LEFT INSIDE THE CANAL. THERE WAS SURGICAL DELAY OF 15 MINUTES IN FIGURING OUT WHAT HAPPENED AND WHAT TO DO. THEY TOOK EVERYTHING OUT AND OPENED A SMALLER 12.0MM RIA HEAD (STICKERS ATTACHED). SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE 12.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14774847 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) WITH REAMER / IRRIGATOR / ASPIRATOR (RIA) 2 PROCEDURE, WHILE REAMING THE PATIENTS FEMORAL CANAL WITH RIA 2 REAMER HEAD BROKE OFF. REAMER HEAD WAS REMOVED WITH BALL TIP GUIDE ROD. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 12.5MM 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 14651665 ↗
• InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN CASE FOR A PROPHYLACTIC NAIL, WHILE REAMING WITH THE RIA, THE ANTERIOR CORTEX OF THE DISTAL THIRD TIBIA WAS PERFORATED. THE SURGEON HAD ALREADY PLANNED TO PLACE A PROPHYLACTIC NAIL, AND PROCEEDED WITH THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 12.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 11379510 ↗
• InjuryJan 26, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, THE REAMER HEAD FOR RIA BROKE AND LEFT 3 SMALL FRAGMENTS IN THE FEMUR WHICH DID NOT RETIRE. THE PATIENT IS NOT HARMED BUT THE DEVICE WAS BROKEN. THE ITEMS THAT WERE IMPLANTED SOMEHOW MATERIALIZE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 12.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11229346 ↗
• InjuryDec 22, 2020Break; Entrapment of Device; Break; Entrapment of Device

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5097549. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED THAT ON (B)(6) 2020, THE FLANGE ON A REAMER HEAD FOR REAMER, IRRIGATOR, ASPIRATOR (RIA) 2 BROKE OFF AND BECAME LODGED IN THE PATIENT'S FEMUR. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN RIA TUBE ASSEMBLY (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN RIA DRIVER SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Foreign Body In Patient

  MAUDE report 11057629 ↗
• MalfunctionNov 25, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING USAGE OF THE NEW REAMER IRRIGATOR ASPIRATOR (RIA) 2 DEVICE, THE REAMER HEAD DISCONNECTED FROM THE REAMER ASSEMBLY 2 IN DRIVE SHAFT IN THE PATIENT TIBIAL CANAL. SURGEON HAD TO USE TWO DIFFERENT SIZES OF THE REAMER HEADS. WHEN PULLED OUT THE FIRST REAMER HEAD, THE CONNECTING PART OF THE REAMER HEAD BROKE AND SURGEON HAD TO RETRIEVE IT FROM THE PATIENT CANAL. THERE WAS A SURGICAL DELAY OF 20 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: RIA 2 BONE HARVESTING KIT 520MM STERILE (PART# 03.404.000S, LOT# 70P7739, QUANTITY# 1), RIA 2 REAMING KIT 520MM STERILE (PART# 03.404.001S, LOT# 29P9237 , QUANTITY# 1). THIS REPORT IS FOR 1 12.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10907203 ↗
• MalfunctionNov 25, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING USAGE OF THE NEW REAMER IRRIGATOR ASPIRATOR (RIA) 2 DEVICE, THE REAMER HEAD DISCONNECTED FROM THE REAMER ASSEMBLY 2 IN DRIVE SHAFT IN THE PATIENT TIBIAL CANAL. SURGEON HAD TO USE TWO DIFFERENT SIZES OF THE REAMER HEADS. WHEN PULLED OUT THE FIRST REAMER HEAD, THE CONNECTING PART OF THE REAMER HEAD BROKE AND SURGEON HAD TO RETRIEVE IT FROM THE PATIENT CANAL. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: RIA 2 BONE HARVESTING KIT 520MM STERILE (PART# 03.404.000S, LOT# 70P7739, QUANTITY# 1), RIA 2 REAMING KIT 520MM STERILE (PART# 03.404.001S, LOT# 29P9237, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 12.5MM 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 10907056 ↗
• InjurySep 15, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A MID SHAFT FEMUR FRACTURE PROCEDURE. DURING THE PROCEDURE, WHILE THE SURGEON WAS REAMING THE FEMORAL SHAFT WITH A REAMER/ IRRIGATOR/ ASPIRATOR (RIA) 2, THE TIP OF THE REAMER HEAD BROKE OFF IN THE CANAL. THE FRAGMENT WAS EXTRICATED EXCEPT FOR A FEW METAL SHAVINGS THAT REMAINED IN THE CANAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN (10) MINUTE SURGICAL DELAY. CONCOMITANT DEVICES: RIA 2 (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 12.5MM REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 10536144 ↗