NA 309.480Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982185754), received between Mar 2, 2017 and Feb 5, 2026 — classified as 5 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Break

  IT WAS REPORTED INTRA-OPERATIVELY, A DRILL BIT BROKE. WHILE TRYING TO RETRIEVE THE BROKEN DRILL BIT, THE HOLLOW REAMER BROKE. ANOTHER DRILL BIT WAS USED TO REDRILL SUCCESSFULLY. A 6.5MM RECON SCREW GOT STUCK AFTER TAPPING MULTIPLE TIMES. WHILE TRYING TO REMOVE THE STUCK SCREW, A SCREWDRIVER WAS DAMAGED. AN EXTRACTION SCREW ALSO STRIPPED DURING THE SURGERY. THE SURGEON WAS NOT ABLE TO IMPLANT THE RECON SCREW SO CHANGED TO THE SURGICAL PLAN TO ACCOMMODATE TRANSVERSE LOCKING ONLY. THE PROCEDURE WAS COMPLETED WITH A ONE-HUNDRED TWENTY (120) MINUTE DELAY.

  Patient problems: Insufficient Information

  MAUDE report 24272336 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024 , THE TIP OF THE TREPHINE IS FRACTURED DURING ITS USE FOR EXTRACTION OF BROKEN SCREW. THIS REPORT IS FOR SPARE REAMER TUBE FOR HOLLOW REAMER FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201395 ↗
• MalfunctionMar 20, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPARE REAMER TUBE NEEDED TO BE REPLACED DUE TO WEAR AND TEAR. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SPARE REAMER TUBE FOR HOLLOW REAMER (309.450). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16574073 ↗
• InjuryMay 24, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, WHILE REAMING OVER A SCREW HEAD, A HOLLOW REAMER BROKE INTO FRAGMENTS. ACCORDING TO THE REPORT, SOME OF THE FRAGMENTS WERE REMOVED, HOWEVER IT WAS UNCLEAR IF THEY WERE ALL REMOVED BECAUSE SOME FRAGMENTS WERE SEEN ON THE X RAY. IT WAS UNKNOWN IF FRAGMENTS WERE PORTIONS OF THE SCREW OR THE HOLLOW REAMER. THE SURGERY PROCEEDED WITHOUT DELAY AND THE PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14489013 ↗
• MalfunctionMay 7, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE PATIENT UNDERWENT REMOVAL SURGERY AND OPEN REDUCTION INTERNAL FIXATION WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM FOR A FRACTURE OF THE SUBTROCHANTERIC FEMUR WHICH OCCURRED AFTER THE PATIENT¿S INITIAL SURGERY. DURING THE SURGERY, IT WAS CONFIRMED THAT THE HEAD OF TWO SCREWS WERE BROKEN; THE SURGEON TRIED TO REMOVE THE SCREWS WITH A HOLLOW REAMER. THE TIP OF THE REAMER TUBE BROKE. THE SURGEON USED ANOTHER REAMER TUBE; HOWEVER, THIS REAMER TUBE ALSO BROKE. THE SURGEON MANAGED TO REMOVE THE BROAD PLATE AND THE NARROW PLATE AND TRIED TO FIX THE TFNA LONG NAIL. WHEN THE SURGEON TRIED TO DRILL THE BONE WITH A NON-SYNTHES INTRAMEDULLARY NAIL DRILL FOR INSERTION OF DISTAL LOCKING SCREW, THE TIP OF THE INTRAMEDULLARY NAIL DRILL WAS DEFORMED BY THE HARDNESS OF THE BONE. THE SURGEON MANAGED TO DRILL AND MAKE A SCREW HOLE. DURING INSERTION OF THE LOCKING SCREW, THE TIP OF THE INTER-LOCK SCREWDRIVER DEFORMED AND COULD NOT BE USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN THIRTY MINUTES DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A SPARE REAMER TUBE FOR HOLLOW REAMER (3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14320937 ↗
• MalfunctionMay 7, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL SURGERY AND OPEN REDUCTION INTERNAL FIXATION WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM FOR A FRACTURE OF THE SUBTROCHANTERIC FEMUR WHICH OCCURRED AFTER THE PATIENT¿S INITIAL SURGERY. DURING THE SURGERY, IT WAS CONFIRMED THAT THE HEAD OF TWO SCREWS WERE BROKEN; THE SURGEON TRIED TO REMOVE THE SCREWS WITH A HOLLOW REAMER. THE TIP OF THE REAMER TUBE BROKE. THE SURGEON USED ANOTHER REAMER TUBE; HOWEVER, THIS REAMER TUBE ALSO BROKE. THE SURGEON MANAGED TO REMOVE THE BROAD PLATE AND THE NARROW PLATE AND TRIED TO FIX THE TFNA LONG NAIL. WHEN THE SURGEON TRIED TO DRILL THE BONE WITH A NON-SYNTHES INTRAMEDULLARY NAIL DRILL FOR INSERTION OF DISTAL LOCKING SCREW, THE TIP OF THE INTRAMEDULLARY NAIL DRILL WAS DEFORMED BY THE HARDNESS OF THE BONE. THE SURGEON MANAGED TO DRILL AND MAKE A SCREW HOLE. DURING INSERTION OF THE LOCKING SCREW, THE TIP OF THE INTER-LOCK SCREWDRIVER DEFORMED AND COULD NOT BE USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN THIRTY MINUTES DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A SPARE REAMER TUBE FOR HOLLOW REAMER (30

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14320526 ↗
• MalfunctionJul 29, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIP PART OF THE SPARE REAMER TUBE FOR HOLLOW REAMER WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR (1) SPARE REAMER TUBE FOR HOLLOW REAMER (309.450). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249659 ↗
• MalfunctionApr 28, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE TIP OF THE SPARE REAM TUBE WAS FOUND TO BE CHIPPED AFTER WASHING IN THE HOSPITAL BEFORE THE SURGERY. IT WAS NOT DAMAGED. THE CHIPPED PARTS WERE ALSO FOUND, AND IT MAY HAVE BEEN DAMAGED DURING CLEANING. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SPARE REAMER TUBE FOR HOLLOW REAMER. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740444 ↗
• InjuryMar 25, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY DUE TO DISTURBING (STÖREND) IMPLANT MATERIAL. THE SURGERY WAS A REGULAR IMPLANT REMOVAL AFTER OSTEOTOMY OF THE FEMUR SHAFT. THE INITIAL OSTEOTOMY WAS PERFORMED IN (B)(6) 2018. THE BROKEN TIP OF THE REAMER TUBE IS IN THE FEMUR CANAL. THE REMOVAL SURGERY WAS COMPLETED AS PLANNED. THE PATIENT OUTCOME WAS UNKNOWN. UPDATED CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN); UNKNOWN LCP 4.5/5.0 BROAD, 12-HOLE PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SPARE REAMER TUBE FOR HOLLOW REAMER (309.450). THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11568404 ↗
• MalfunctionNov 12, 2020Break; Material Deformation; Break; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING LCP PROXIMAL TIBIA PLATE REMOVAL SURGERY, THE SPARE REAMER TUBE, EXTRACTION BOLT, AND CONICAL EXTRACTION SCREW WERE BROKEN AND NONFUNCTIONAL. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING OTHER INSTRUMENTS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER (309.450). THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10831578 ↗
• InjuryJun 25, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE REMOVING A BROKEN SCREW, A HOLLOW REAMER WAS USED TO REMOVE THE BROKEN SCREW AND 2 PIECES BROKE OFF IN THE PATIENT. FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY (B)(4)). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER (309.450). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 10198198 ↗
• MalfunctionDec 23, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED TWO REAMER TUBES WERE BROKEN. IT IS UNKNOWN WHEN THE MALFUNCTION OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511545 ↗
• MalfunctionNov 26, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING SURGICAL PROCEDURE FOR A REMOVAL OF HARDWARE AND REPAIR RIGHT FEMUR FRACTURE, THE TIP OF THE HOLLOW REAMER COMPLETE HAD TWO (2) PIECES BREAK OFF. BOTH PIECES RETRIEVED BY THE SURGEON. THERE IS MINOR SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9376456 ↗
• MalfunctionJun 13, 2019Break; Break

  UPDATE: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A HIP REVISION SURGERY TO REMOVE THE IMPLANTS DUE TO NONUNION. THERE WAS A SURGICAL DELAY OF THREE (3) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN.  THIS (B)(4) CAPTURES INTRA-OPERATIVE EVENT, WHILE (B)(4) WAS CREATED TO CAPTURE POST-OPERATIVE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8698030 ↗
• MalfunctionFeb 4, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS REMOVING A 4.0 CANNULATED SCREW FOR AN UNKNOWN REASON. DURING REMOVAL THE UNKNOWN 4.0 CANNULATED SCREW BROKE. IT WAS REPORTED THAT THE FOLLOWING INSTRUMENTS "BROKE INTRAOPERATIVELY": THE CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS, SPARE REAMER TUBE FOR HOLLOW REAMER, EXTRACTION BOLT FOR 4.5 SCREWS, SPARE REAMER TUBE FOR HOLLOW REAMER, SMALL HANDLE WITH QUICK COUPLING, AND CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. SURGICAL DELAY IS UNKNOWN. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8301607 ↗
• MalfunctionNov 13, 2018Crack; Crack

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING DECONTAMINATION ON AN UNKNOWN DATE, ONE (1) EXTRA-BOLT WAS FOUND CRACKED AND ONE (1) SPAREREAMER TUBE WAS FOUND BROKEN. THERE WERE NO SURGICAL PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8066472 ↗
• MalfunctionAug 13, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A CLEANING PROCEDURE AT THE STERILE DEPARTMENT ON AN UNKNOWN DATE, TWO HOLLOW REAMER SPARE TUBES WERE FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SPARE REAMER TUBE FOR HOLLOW REAMER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7778008 ↗
• MalfunctionAug 13, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A CLEANING PROCEDURE AT THE STERILE DEPARTMENT ON AN UNKNOWN DATE, TWO HOLLOW REAMER SPARE TUBES WERE FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SPARE REAMER TUBE FOR HOLLOW REAMER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7777810 ↗
• MalfunctionJan 31, 2018Break; Break

  IT WAS REPORTED THAT DURING CLEANING AND FUNCTIONAL TESTING IT TURNED OUT THAT THE DEVICE IS BROKEN, A PIECE IS MISSING AND IT IS CRACKED AS WELL. REALIZED AFTER SURGERY. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS COMPLAINT IS FOR ONE (1) REAMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7230881 ↗
• MalfunctionNov 6, 2017Break; Break

  IT WAS REPORTED THAT SPARE REAMER TUBE FOR HOLLOW REAMER BROKE INTRA OPERATIVELY DURING AN UNKNOWN PROCEDURE ON (B)(6) 2017. REPORTEDLY A PORTION OF THE DEVICE SNAPPED OFF. PROCEDURE COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. IT IS UNKNOWN IF THERE WERE ANY SURGICAL DELAYS OR IF FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AND NO UNANTICIPATED X-RAYS TAKEN DUE TO THE INTRAOPERATIVE EVENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE ABOUT THE PATIENT AND REPORTEDLY, ALL AVAILABLE INFORMATION HAS BEEN SUBMITTED AS THE REPORTER WAS NOT PRESENT DURING THE PROCEDURE. THE BROKEN DEVICE WILL BE RETURNED FOR INVESTIGATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7003005 ↗
• InjuryNov 6, 2017Break; Break

  IT WAS REPORTED THAT INITIALLY A PATIENT UNDERWENT A PLACEMENT OF A MEDIAL MALLEOLAR SCREW FOR AN ANKLE VALGUS ON AN UNKNOWN DATE TO CORRECT A DEFORMITY. A HARDWARE REMOVAL WAS SCHEDULED ON (B)(6) 2017 DUE TO THE DEFORMITY HEALING. DURING THE REMOVAL, A 4.0MM CANNULATED SCREW STRIPPED. AS THE SURGEON WAS REMOVING THE SCREW FROM THE MEDIAL MALLEOLUS, THE SCREW HEAD STRIPPED. THE SURGEON USED PLIERS TO BACK THE SCREW OUT. THE HEAD THEN BROKE OFF, SO THE SURGEON USED A TREPHINE TO OPEN AROUND THE SHAFT OF THE SCREW. THE TREPHINE THEN BROKE OFF INSIDE THE PATIENT. THE SURGICAL TEAM THEN USED A CONICAL EXTRACTOR TO REMOVE THE SCREW SHAFT. THE SCREW THEN BROKE OFF INSIDE THE PATIENT. USING THE HARDWARE REMOVAL TOOLS TO EXTRACT THE SCREW, THE SURGERY WAS ABLE TO BE COMPLETED WITH THE REMOVAL OF THE ENTIRE SCREW. THERE WAS ABOUT A TEN (10) MINUTE SURGICAL DELAY. THE PATIENT STATUS IS GOOD. CONCOMITANT DEVICES REPORTED: PLIERS (PART # UNKNOWN, LOT # UNKNOWN, QTY 1), CONICAL EXTRACTOR (PART # UNKNOWN, LOT # UNKNOWN, QTY 1); HARDWARE REMOVAL TOOLS (PART # AND LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER. THIS IS REPORT 2 OF 4 FOR COMPLAINT (

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7002772 ↗
• MalfunctionOct 25, 2017Break; Break

  CONCOMITANT DEVICES REPORTED: HOLLOW REAMER COMPLETE FOR 4.5MM SCREWS (PART# 309.450, LOT# 9167235, QUANTITY 1).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6978125 ↗
• MalfunctionJun 15, 2017Break; Break

  THIS REPORT IS FOR A VETERINARY CASE. THERE WAS NO HUMAN PATIENT INVOLVEMENT. IT WAS REPORTED THE INITIAL IMPLANT PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE APPROXIMATELY FIVE (5) YEARS PRIOR TO THE DATE OF THIS REPORT TO TREAT A CANNON BONE (RIGHT METATARSUS) FRACTURE. THE INITIAL HARDWARE REMOVAL ATTEMPT WAS DONE ON (B)(6) 2017 AS A 4.5MM SCREW WAS CAUSING SOFT TISSUE IRRITATION. DURING THE 4.5MM SCREW REMOVAL THE HEAD OF THE SCREW BROKE OFF AND SHAFT WAS RETAINED IN THE PATIENT (CAPTURED UNDER RELATED COMPLAINT (B)(4)). A REAMER TOOL WAS REQUIRED TO REMOVE THE REMAINING SCREW SHAFT. A PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2017 FOR REMOVAL OF A SCREW SHAFT. AS SURGEON WAS PREPARING TO REMOVE THE SCREW SHAFT ON (B)(6) 2017, HE BEGAN REAMING MANUALLY AND WITHOUT THE USE OF POWER. THE SURGEON WAS UNABLE TO GET PURCHASE ON THE BONE AND TRIED PUSHING ON THE HOLLOW REAMER TO GET IT TO BITE, WHICH CAUSED FOUR (4) OF THE SIX (6) INSTRUMENT TEETH TO BREAK OFF. ALL BROKEN TEETH WERE EASILY RECOVERED. THE SURGEON COMMENTED THAT THE REMODELED BONE WAS VERY DENSE, CAUSING DIFFICULTY DURING REAMING. THE SURGEON CONTINUED THE PROCEDURE AND SUCCESSFULLY REMOVED THE SCREW SHAFT. TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6643433 ↗
• MalfunctionMar 2, 2017Break; Break

  THE BREAKAGE WAS DETECTED BEFORE THE SURGERY. DURING SURGERY AFTERWARDS WAS NO PATIENT HARM AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6374754 ↗