NA 310.21Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886982186188), received between Apr 19, 2017 and Feb 25, 2026 — classified as 11 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (24 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ORIF OF A RIGHT ANKLE FRACTURE WHEN DRILLING FOR A 2.7 MM CORTEX SCREW USING A 2.0 MM DRILL BIT, THE DRILL BIT BROKE OFF INSIDE OF THE TIBIA AND IS NOW ENCASED IN BONE. THE DRILL BIT PIECE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24446942 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, TWO SCREWS WERE NOT ENGAGING WITH THE SCREWDRIVER AND A DRILL BIT BROKE. IT WAS NOTED FRAGMENTS WERE GENERATED BUT WERE EASILY REMOVED WITH NO ADDITIONAL MEDICAL INTERVENTION NEEDED. THERE WAS NO SURGICAL DELAY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231313 ↗
• MalfunctionJan 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE SETTING UP FOR CASE, IT WAS NOTED THAT NEITHER OF THE 2.0MM DRILLS BITS THAT WERE STOCKED IN THE SET WERE FITTING INTO THE DRILL AO QUICK CONNECT. ITEMS WERE TRIED IN ANOTHER DRILL, AND THE DRILL BITS STILL DID NOT FIT INTO THE QUICK CONNECT. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079420 ↗
• MalfunctionJan 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE SETTING UP FOR CASE, IT WAS NOTED THAT NEITHER OF THE 2.0MM DRILLS BITS THAT WERE STOCKED IN THE SET WERE FITTING INTO THE DRILL AO QUICK CONNECT. ITEMS WERE TRIED IN ANOTHER DRILL, AND THE DRILL BITS STILL DID NOT FIT INTO THE QUICK CONNECT. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079381 ↗
• MalfunctionDec 31, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT WHILE USING A 2.0 DRILL BIT, THE TIP BROKE OFF AND WAS EMBEDDED IN THE BONE. IT WAS IDENTIFIED AS THE DRILL BIT CAME BACK TO THE ST THAT ABOUT 1 INCH OF THE DRILL BIT WAS MISSING. IT WAS IDENTIFIED THAT IT WAS IN THE BONE USING X-RAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21048634 ↗
• MalfunctionJan 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON DECEMBER 11, 2023, THAT THE PRODUCT WOULD NOT CLICK INTO THE QUICK CONNECT ATTACHMENT. NO PATIENT INVOLVEMENT WAS THERE. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435136 ↗
• MalfunctionNov 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE DRILL BIT SEEMED TO BE DAMAGED AND WOULD NOT THREAD INTO THE QUICK CONNECT SCREWDRIVER. THE TOP OF THE DRILL BIT QUICK CONNECT PORTION APPEARED TO BE OFF CENTER COMPARED TO OTHER DRILL BITS THAT WOULD ATTACH CORRECTLY. THIS REPORT IS FOR A 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18184988 ↗
• MalfunctionNov 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE TO FIX A DISTAL HUMERUS FRACTURE USING VARIABLE ANGLE ELBOW PLATING SYSTEM, THE TIP OF THE DRILL BIT THE SURGEON WAS USING (310.21: 2.0 DRILL BIT) BROKE INSIDE THE BONE WHILE IN USE. THIS CAUSED THE SURGEON TO HAVE TO REMOVED ALL HARDWARE AND USE A TPS BURR TO DIG THE PIECE OF THE DRILL BIT OUT AND THEN RE-FIXATE WITH THE PLATE. THE SURGERY WAS DELAYED FOR 20 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18065749 ↗
• MalfunctionSep 28, 2023Break; Entrapment of Device; Break; Entrapment of Device

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5145057, A COPY IS ATTACHED. IT WAS REPORTED THAT ON (B)(6) 2023, WHEN THE SURGEON WAS PERFORMING A RIGHT TOTAL SHOULDER ARTHROPLASTY ON PATIENT, THE 2.0 DRILL BIT BROKE OFF IN THE HUMERAL HEAD AREA OF THE SHOULDER. IT WAS FURTHER REPORTED THAT THE TIP OF DEVICE WAS LEFT IN PATIENT¿S ARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER MEDICAL INTERVENTION REQUIRED. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17839864 ↗
• MalfunctionMar 25, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, A 2.0 DRILL BIT BROKE WHILE DRILLING. THE TIP WAS RETRIEVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR A 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13908975 ↗
• MalfunctionDec 7, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SURGEON OVER BENT THE DRILL UPON AGGRESSIVELY DRILLING TO OBTAIN A CERTAIN ANGLE. THE TIP OF THE DRILL BIT BROKE OFF AND WAS RETAINED INSIDE THE PATIENT, AS DECIDED BY THE SURGEON. SINCE THE TIP IS IN-LINE WITH THE IMPLANTED SCREW IT DID NOT COME OUT. THE TIP WAS NOT VISIBLE ON THE X-RAY AND WOULD BE DIFFICULT TO REMOVE IT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12952196 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WILL UNDERGO REMOVAL OF A BROKEN TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NEAR THE INSERTION POINT OF THE TFNA SCREW AND THAT THE PATIENT HAD A NON-UNION. IT WAS ORIGINALLY IMPLANTED ON (B)(6) 2021. THERE WAS PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), TFNA END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN NAIL DISTAL LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 105MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715444 ↗
• InjuryFeb 26, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION CLACANEUS, RIGHT AND THE DRILL BIT 2.0MM BROKE. THE DRILL SHAFT WAS REMOVED. THE BROKEN DRILL TIP REMAINED IN THE PATIENT. THE SURGEON SELECTED A REPLACEMENT DRILL AND CONTINUED WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF ONE (1) MINUTE THIS REPORT INVOLVES ONE (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11385638 ↗
• MalfunctionJan 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING DISTAL FIBULA SURGERY USING VARIABLE ANGEL (VA) ANKLE SYSTEM, ONE (1) 2.0MM DRILL BIT BROKE AND ONE (1) SCREWDRIVER HANDLE WAS DAMAGED. THE DRILL BIT 2.0MM BROKE DURING DRILLING OF PROXIMAL SCREW AND THE BROKEN DRILL SHAFT WAS RETAINED IN DRILL. THE BROKEN DRILL TIP FELL ONTO THE FLOOR, A NEW DRILL BIT WAS SELECTED AND THE PROCEDURE CONTINUED WITHOUT INCIDENT. THE SCREWDRIVER HANDLE'S ROTATING CAP BROKE OFF DURING USE. THE SURGEON CONTINUED USE OF SCREWDRIVER WITHOUT INCIDENT. THERE WERE TWO (2) MINUTES OF SURGICAL DELAY. FRAGMENTS WERE EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME AS PLANNED. CONCOMITANT DEVICE REPORTED: UNK - DRILL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11224429 ↗
• InjurySep 22, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE DRILL BIT WHILE DRILLING AND STAYED IN PATIENTS BONE. THE DRILL BIT MADE CONTACT WITH ANOTHER SCREW. FRAGMENT WERE GENERATED BUT IT IS UNKNOWN IF THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE IS NO SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: SCREWS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); POWERED DRIVERS/HANDPIECES: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10567518 ↗
• MalfunctionJan 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS ALSO REPORTED THAT THERE WAS NO SURGICAL DELAY. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591320 ↗
• InjuryNov 13, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE TIP OF THE DRILL BIT BROKE OFF ON THE PATIENT'S DISTAL TIBIA. THE SURGEON STATED THAT THE DRILL BIT HIT ANOTHER CORTEX SCREW THROUGH THE LOCKING COMPRESSION PLATE (LCP) T-PLATE WHICH HAD ALREADY BEEN PLACED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND RETAINED. PATIENT STATUS IS OK. CONCOMITANT DEVICE REPORTED: CORTEX SCREW ( PART# 202.876, LOT# UNKNOWN, QUANTITY 1) LOCKING COMPRESSION PLATE (LCP) T-PLATE ( PART# 249.615, LOT# UNKNOWN, QUANTITY 1) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9316929 ↗
• InjurySep 3, 2019Break; Break

  09/24/2019: UPDATED EVENT DESCRIPTION:IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION (ORIF) DUE TO THE NON-UNION FRACTURED DISTAL FIBULA, THE INITIAL INJURY WHICH LED TO THE NON-UNION WAS A GUNSHOT WOULD RESULTING IN A FRACTURED FIBULA. THE FRACTURE WAS TREATED NON OPERATIVELY AND RESULTED IN A NON-UNION WHERE THE ENDS OF THE NON-UNION SITE WERE HARD NON VASCULARIZED SCLEROTIC BONE. WHILE DRILLING WITH A DRILL BIT THE DRILL BIT BROKE IN THE PATIENT'S BONE, THE SURGEON WAS UNABLE TO RETRIEVE THE PIECE OF THE BROKEN DRILL BIT. WHEN THE EVENT OCCURRED THEY ATTEMPT TO RETRIEVE THE DRILL BIT USING SMALL CLAMPS, BUT WAS NOT UNSUCCESSFUL. FRAGMENTS WERE GENERATED BUT WERE NOT REMOVED FROM THE PATIENT. THE FRAGMENTS WERE LOCATED IN THE PATIENT'S FIBULAR CANAL, APPROXIMATELY FIFTEEN CM PROXIMAL TO THE DISTAL TIP OF THE FIBULA. THERE WAS A SURGICAL DELAY OF FIVE MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN CLAMPS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8957811 ↗
• MalfunctionFeb 6, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN ORTHOPEDIC PROCEDURE, THE DRILL BIT WAS BROKEN. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310269 ↗
• InjuryOct 30, 2018Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF AN ACETABULUM, AN OSTEOTOMY WAS REPAIRED USING DRILL BITS AND CANCELLOUS SCREWS. WHILE DRILLING, TWO OF THE DRILL BITS BROKE AND THE FRAGMENTS REMAINED IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN 4.0MM CANCELLOUS SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8020998 ↗
• InjuryOct 30, 2018Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF AN ACETABULUM, AN OSTEOTOMY WAS REPAIRED USING DRILL BITS AND CANCELLOUS SCREWS. WHILE DRILLING, TWO OF THE DRILL BITS BROKE AND THE FRAGMENTS REMAINED IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN 4.0MM CANCELLOUS SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8020817 ↗
• InjuryOct 4, 2018Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2018, THE DRILL BIT WAS BROKEN DURING AN OPEN REDUCTION INTERNAL FIXATION OF DISTAL HUMERUS PROCEDURE. THE BROKEN DRILL BIT PIECE WAS LEFT INSIDE THE RIGHT DISTAL HUMERUS. SURGICAL OUTCOME WAS SUCCESSFUL. PATIENT OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7935627 ↗
• InjurySep 4, 2018Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN ELBOW SURGERY. DURING THE SURGERY, THE TIP OF THE DRILL BIT BROKE IN THE PATIENT WHILE DRILLING A PILOT HOLE FROM THE MODULE OF THE MODULAR FOOT SYSTEM. APPROXIMATELY ONE (1) CENTIMETER OF THE DRILL BIT STAYED IN THE PATIENT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 2.7 MM FOOT MODULE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1) . THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7843459 ↗
• MalfunctionDec 8, 2017Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRILL BIT BROKE OFF DURING A DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2017. ALL FRAGMENTS WERE RETRIEVED. A NEW DRILL BIT WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7101245 ↗
• InjuryOct 31, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A DISTAL TIP OF A DRILL BIT BROKE INTO 2 PIECES DURING A PROCEDURE ON (B)(6) WHILE ATTEMPTING TO CREATE A HOLE FOR A 2.7MM CORTEX SCREW. THE SURGEON DRILLED THROUGH BOTH CORTICES OF THE PROXIMAL ULNA AT APPROXIMATELY A TWENTY DEGREE ANGLE TO THE JOINT SURFACE. UPON REMOVING THE DRILL BIT, IT WAS DISCOVERED THAT THE TIP HAD BROKEN OFF INTO THE PATIENT'S PROXIMAL ULNA IN THE METAPHYSEAL REGION. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND WERE NOT RECOVERED. NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DRILL BIT READILY AVAILABLE. ADDITIONAL FLUOROSCOPY TIME WAS REQUIRED AFTER THE SURGERY TO ENSURE SATISFACTORY RESULTS, HOWEVER THERE WAS NO SURGICAL DELAY DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN ACCEPTABLE CONDITION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6991914 ↗