NA 03.404.019SRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982273970), received between Mar 26, 2020 and Nov 24, 2025 — classified as 5 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. 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-0574-2021 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Break; Break

  DURING A PROCEDURE, THE REAMER HEAD BROKE AND BECAME LODGED ON A GUIDE WIRE. THE DEVICE SEPARATED INTO MULTIPLE PIECES WHILE REAMING THE CANAL; HOWEVER, NO FRAGMENTS WERE LEFT INSIDE THE PATIENT, AND THE PATIENT EXPERIENCED NO HARM OR ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631960 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT WHILE SURGEON WAS UTILIZING THE RIA SYSTEM APPROPRIATELY, THE RIA HEAD BECAME DISENGAGED FROM THE REAMER SHAFT. THE REAMER SHAFT WAS REMOVED AND THE RIA HEAD WAS THEN REMOVED USING THE 2.5MM REAMING ROD. UPON REMOVAL OF ALL COMPONENTS, X-RAY IMAGING SHOWED 4 SMALL METAL PIECES TRAPPED WITHIN THE PROXIMAL FEMUR CANAL. FRAGMENTS WERE GENERATED AND THE PIECES WERE ALL SUCCESSFULLY RETRIEVED WITH SUCTION AND A GRASPER. GRASPERS WERE USED TO RETRIEVE THE PIECES. SURGERY WAS DELAYED BY 30 MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889693 ↗
• 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) 11.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19828911 ↗
• 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 18392311 ↗
• MalfunctionNov 15, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 26-OCTOBER-2023 DURING AN UNKNOWN PROCEDURE, THE REAMER HEAD IN QUESTION BROKE. ONLY THE END OF THE CORTICES BECAME EMBEDDED IN THE BONE, THE LEGS THAT HOLD THE BUR BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 11.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18139405 ↗
• 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 18013587 ↗
• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE RIA 2 WAS BEING USED TO HARVEST BONE GRAFT. THE SURGEON ASSEMBLED THE RIA WITH DIRECTION FROM THE SALES CONSULTANT. THEY BOTH HEARD AN AUDIBLE CLICK WHEN THE RIA SHAFT WAS INSERTED INTO THE TUBE ASSEMBLY AND IT WAS SECURE WHEN TESTED WITH A LIGHT PULL BACKWARDS. THE RIA HEAD WAS SNAPPED ONTO THE END AND WAS FLUSH WITH THE TUBE AND SHAFT. THE SURGEON BEGAN TO REAM, AND IT WAS VERY DIFFICULT TO ADVANCE THE REAMER. IT SOUNDED LIKE METAL WAS GRINDING, SO THE SURGEON STOPPED AND LOOKED WITH X-RAY. IT WAS SEEN THAT THE RIA HEAD WAS NOT ATTACHED TO THE DRIVE SHAFT, AND THERE WERE METAL FRAGMENTS IN THE FEMUR CANAL. THE RIA WAS REMOVED FROM THE PATIENT, AND THE BALL TIP GUIDE WIRE WAS REMOVED FROM THE FEMUR, PULLING THE RIA HEAD WITH IT. A DIFFERENT DRIVE SHAFT AND NEW RIA HEAD WAS USED TO FINISH TAKING BONE GRAFT. THE SURGEON SPENT THE NEXT HOUR USING SMALL LING GRASPERS AND OTHER INSTRUMENTS TO FISH THE METAL FRAGMENTS OUT OF THE CANAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 60-MINUTE DELAY. IT WAS VERY DIFFICULT AND TIME CONSUMING TO REMOVE THE FRAGMENTS, BUT THEY WERE ALL SUCCESSFULLY REMOVED. THIS REPORT INVOLVES ONE 11.5MM REAMER HEAD F

  Patient problems: Insufficient Information

  MAUDE report 17994622 ↗
• MalfunctionAug 29, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS USING THE RIA 2 SYSTEM TO REAM THE FEMUR TO GET BONE GRAFT FOR A PATIENT WHO WAS GETTING A WRIST FUSION. THE SURGEON USED A 12MM OPENING REAMER TO OPEN THE GREATER TROCH. INITIALLY, HE WANTED TO USE THE 12MM REAMER HEAD BUT THAT DROPPED ON THE FLOOR, SO THE 11.5 REAMER HEAD WAS USED. HE ATTACHED THE REAMER HEAD TO THE RIA 2 REAMER SHAFT AND PROCEEDED TO START TO REAM. THE PATIENT HAS A VERY SMALL BONE AND IT WAS BELIEVED THAT THE SURGEON OVER BENT THE REAMER SHAFT, CAUSING THE LEGS OF THE REAMER HEAD TO SNAP OFF INTO THE PATIENT'S INTERMEDULLARY CANAL. HE CONTINUED TO USE THE REAMER HEAD TO THE DISTAL FEMUR. WHEN HE BEGAN TO BACK THE REAMER OUT, THAT IS WHEN IT WAS NOTICED THAT THE DEVICE WAS DETACHING FROM THE SHAFT. THIS WAS VISIBLE UNDER UNSEEN OF X-RAY. THE DEVICE AND THE GUIDE WIRE WITH THE 11.5 ATTACHED WAS PROCEEDED TO BE PULLED OUT OF THE PATIENT. HE THEN TOOK AN X-RAY OF THE PROXIMAL FEMUR AND COULD SEE 4 SMALL PIECES OF METAL IN THE PATIENT. THE CASE WAS PROCEEDED AND MOVED UP TO A 12.5 REAMER HEAD, WHICH HAD NO ISSUES. IT WAS BELIEVED THAT THE OVER BENDING AND TORQUE ON THE REAMER HEAD CAUSED THE BREAKING. IT WAS UNKNO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643695 ↗
• MalfunctionMar 10, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE EVENT INVOLVED THE RIA 2 REAMER SYSTEM AND A 11.5 REAMER HEAD WHERE THE CONS THAT HOLD THE REAMER HEAD ON TO THE REAMER SHAFT BROKE OFF INSIDE THE PATIENT. PATIENT WAS NOT HARMED THEY WERE ABLE TO RETRIEVE ALL OF THE METAL CONS. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 11.5MM 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 16522998 ↗
• InjuryAug 5, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING IM NAILING OF A TIBIA WITH BONE GRAFT, THE REAMER/IRRIGATOR/ASPIRATOR (RIA) 2 BONE HARVESTING KIT AND RIA 2 11.5MM 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 TIBIA. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES WHILE RETRIEVING THE METAL FRAGMENTS. THE SURGEON SIZED THE TIBIAL CANAL AT 10MM AND THEN CHOSE A 11.5MM REAMER HEAD. WHEN THE SURGEON INSERTED THE RIA 2 INSIDE THE TIBIA AND BEGAN TO HARVEST GRAFT THE REAMER HEAD THEN BROKE FROM THE RIA 2 SHAFT. THIS REPORT IS FOR ONE (1) 11.5MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15178215 ↗
• InjuryFeb 11, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON JANUARY 15, 2022, DURING A PROCEDURE THE REAMER/IRRIGATOR/ASPIRATOR (RIA) 2 REAMER HEAD BROKE INTO FIVE PIECES (1 HEAD/CUTTING FLUTES, 4 CONNECTING PRONGS). REAMER HEAD SNAPPED AT THE JUNCTURE OF THE CUTTING FLUTES AND CONNECTING PRONGS. THIS OCCURRED AS THE RIA 2 HEAD CROSSED A DISTAL BEND PLACED IN THE 2.5MM BALL TIP REAMING ROD BY THE SURGEON, AS IT IS COMMON PRACTICE IN MOST REAMING PROCEDURES. THE RIA 2 HEAD/CUTTING TIP WAS RETRIEVED FROM THE PATIENT. THE FOUR PRONGS REMAINED AS FOREIGN BODIES INSIDE THE PATIENT. THREE OF THE PRONGS REMAINED INSIDE THE MEDULLARY CANAL OF THE FEMUR, IMPACTED AGAINST THE INTERNAL CORTEX AS THE NAIL WAS IMPLANTED. A SINGLE PRONG APPEARED TO HAVE ESCAPED THE CANAL THROUGH THE FRACTURE SITE INTO THE SOFT TISSUE. THIS FRAGMENT WAS NOT RETRIEVED DURING THIS PROCEDURE. THERE WAS SURGICAL DELAY OF 15-20 MINUTES DUE TO THE REPORTED EVENT. NO ADVERSE PATIENT OUTCOME WAS NOTED AT THE TIME. POST-OP OUTCOME OF THE PATIENT IS UNKNOWN OUTSIDE OF THIS PROCEDURE. 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: Foreign Body In Patient

  MAUDE report 13518363 ↗
• MalfunctionJun 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE FOR UNKNOWN REASON. WHILE REAMING THE FEMUR WITH A 10.5MM REAMER IRRIGATOR ASPIRATOR (RIA) 2 HEAD, THE HEAD BROKE OFF AND LEFT THE FOUR TABS IN THE FEMUR. THEN OPENED A 11.5 HEAD, AND IT BROKE THE SECOND OR THIRD IN AND OUT MOTION. THE SURGEON THEN PASSED REGULAR REAMER TO SIZE 11MM AND COMPLETED THE CASE WITH AN ADDITIONAL 11.5MM RIA 2 HEAD. CASE DELAYED BY 40 MINUTES. THE SURGEON RETRIEVE THE 8 METAL TABS THAT WERE LEFT FROM BROKEN HEADS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 40 MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1)11.5MM REAMER HEAD FOR RIA 2 STERILE THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12069615 ↗
• 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) 11.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10907052 ↗
• MalfunctionNov 10, 2020Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE SURGEON WAS USING REAMER / IRRIGATOR / ASPIRATOR (RIA) 2 ON THE LEFT TIBIA. IN THE PROCESS OF USING RIA, THE 11.5MM REAMER HEAD CAME OFF THE DRIVESHAFT AND BECAME STUCK IN THE CANAL. THE PRONGS OFF THE 11.5MM REAMER HEAD BROKE OFF IN THE CANAL AND WERE STUCK IN THE TIBIAL CANAL AND HAD TO BE TAKEN OUT. FRAGMENTS WERE GENERATED. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - RIA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1), UNKNOWN RIA 2 DRIVE SHAFT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 11.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817988 ↗
• MalfunctionSep 29, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE BACK END OF THE RIA 2 BROKE WHEN THE SURGEON WAS PULLING THE REAMER OUT AFTER REAMING. AN RIA 2 BONE HARVESTING KIT WAS USED INSTEAD OF THE BROKEN DEVICE. THERE WAS A SURGICAL DELAY OF THIRTY (30) TO FORTY-FIVE (45) MINUTES. THE PATIENT WAS REPORTED AS FINE. CONCOMITANT DEVICE REPORTED: RIA 2 DRIVE SHAFT (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 11.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10600141 ↗
• InjuryAug 12, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING BONE GRAFTING ON (B)(6) 2020, THE 11.5MM AND 10.5MM REAMER/ IRRIGATOR/ ASPIRATOR (RIA 2) REAMER HEADS WERE SHEARED OFF IN THE CANAL AND LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN RIA 2 DRIVE SHAFT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 11.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10397006 ↗
• MalfunctionJun 22, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS USING RIA 2 TO COLLECT BONE. ALL STEPS HAD BEEN FOLLOWED PER TECHNIQUE GUIDE. CANAL WAS MEASURED AT 10MM. 1.5MM WAS ADDED TO THE MEASUREMENT AS DESCRIBED IN TECHNIQUE GUIDE AND STARTED WITH AN 11.5 REAMER HEAD. UPON REAMING FOR BONE THE REAMER DID NOT ADVANCE MUCH BEYOND THE LESSER TORCH. IT WAS DECIDED TO MOVE DOWN TO A SMALLER SIZE. WHEN EXTRACTING, THE REAMER THE HEAD HAD DISENGAGED FROM THE SHAFT AND IT WAS NOTICED THAT THERE WERE METAL FRAGMENTS ON XRAY IN THE CANAL. THE BALL TIP GUIDE WAS REMOVED, AND THE METAL FRAGMENTS WERE EXTRACTED WITH A PITUITARY RONGUER. FRAGMENTS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A FIFTEEN (15) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: RIA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), SCREWDRIVERS: SHAFTS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) 11.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10178337 ↗
• InjuryJun 15, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE FOR POLY TRAUMA INCLUDING BILATERAL FEMUR FRACTURES. DURING THE PROCEDURE, THE HEAD OF A REAMER HEAD FOR REAMER IRRIGATOR ASPIRATOR (RIA2) SNAPPED OFF IN THE 1 CANAL WHILE TRYING TO BRING THE RIA BACK OUT AFTER REAMING. THE HEAD WAS RETRIEVED, AND A SMALL COUPLE OF PIECES REMAINED IN THE CANAL. THE SURGEON ATTEMPTED TO REAM THE SECOND FEMUR WITH ANOTHER REAMER HEAD FOR REAMER IRRIGATOR ASPIRATOR (RIA2), BUT THE TIP SNAPPED IN THE CANAL ALSO, AND STARTED TO BACK IT UP TO CLEAR A BUTTERFLY FRAGMENT THAT WAS IMPEDING THE INSERTION OF THE REAMER. THE HEAD OF THE SECOND REAMER HEAD FOR REAMER IRRIGATOR ASPIRATOR (RIA2 WAS ALSO RETRIEVED. THE FLEXIBLE REAMERS WERE USED FOR BACK-UP. THE CASE COMPLETED SUCCESSFULLY, AND THERE WAS A FIFTEEN (15) MINUTE DELAY BETWEEN THE TWO SIDES. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 12.0MM REAMER HEAD FOR RIA 2 STERILE (PART NUMBER 03.404.020S, LOT 30P7600, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 11.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10152707 ↗
• InjuryMar 26, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING REAMING AT THE RIGHT FEMUR TO COLLECT BONE GRAFT, THE REAMER HEAD BROKE. THE REAMER HEAD WAS REMOVED WITH A GUIDE WIRE BUT THERE WERE SOME FRAGMENTS RETAINED IN THE FEMUR. THERE WAS AN ATTEMPT TO SUCTION OUT THE FRAGMENTS BUT THAT FAILED. THE GUIDE WIRE WAS BENT IN AN EXTREME CURVE TO PREFERENTIALLY REAM AND COLLECT RIA GRAFT FROM DISTAL FEMUR. THE SURGEON FORCED THE RIA REAMER DOWN OVER THE BEND OF THE WIRE AND BROKE THE REAMER HEAD. FRAGMENTS OF THE REAMER HEAD WERE LEFT IN THE FEMUR. THE REAMER HEAD WAS REMOVED VIA THE BALL TIP GUIDE WIRE. DURING OPENING THE ENTRY HOLE, THE TIP OF A STEPPED CANNULATED DRILL BIT BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: GUIDE WIRE (PART# 351.706S, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9882347 ↗