NA 03.008.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886982066855), received between Jun 21, 2017 and Feb 12, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (17 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Device-Device Incompatibility

  CONNECTING ARM WOULD NOT LINE UP TO NAIL. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322928 ↗
• MalfunctionNov 24, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE INSERTION HANDLE HAD A DAMAGED TIP AND APPEARED BENT OR WARPED DURING AN INTRAOPERATIVE ATTEMPT TO CONNECT IT TO A HINDFOOT NAIL. THE HANDLE WAS UNABLE TO CONNECT ONTO THE NAIL INITIALLY, RESULTING IN A DELAY OF APPROXIMATELY THREE TO FOUR (3-4) MINUTES BEFORE SUCCESSFUL ASSEMBLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631383 ↗
• MalfunctionMar 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DURING THE CASE IT WAS DISCOVERED THAT THE INSERTION HANDLE DID NOT FIT THE NAIL WELL. ON INVESTIGATION AFTER THE CASE, IT APPEARS IT HAS BEEN BENT. IT WAS ABLE TO CONNECT BY USING FORCE. THE SURGERY WAS DELAYED 2 MINUTES. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689332 ↗
• MalfunctionNov 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE AIMING ARM MISSED PROXIMAL LOCKING SCREWS. THE AIMING ARM CONSTRUCT SEEMS TO LOOSE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598696 ↗
• MalfunctionJan 12, 2024Break; Break

  I WAS REPORTED THAT ON (B)(6), 2023, THE ITEM WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505442 ↗
• MalfunctionSep 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17788331 ↗
• MalfunctionSep 12, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INTRA-OP THE ISSUE WAS REPORTED THAT HAPPENED USING AN EVALUATION SET. ONE OF THE INSTRUMENTS IN THE KIT IS WORN DOWN AND NEEDS TO BE REPLACED. AT THE END OF THIS INSTRUMENT THERE ARE TABS THAT ARE WORN DOWN AND TWISTED. THIS WILL NOT ALLOW THE NAIL TO CONNECT ONTO THE INSTRUMENT. THERE WAS NO SURGICAL OR PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX.. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729639 ↗
• MalfunctionJan 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREW MISSED SEVERAL TIMES IN THE TALUS THROUGH THE AIMING ARM OF THE HAN NAIL. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES AND A SURGICAL DELAY OF 60 MINS OCCURRED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) INSRT H&LE F/HINDFOOT ARTHRO NAIL-EX. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16187058 ↗
• MalfunctionAug 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 19-JULY-2022, THE SURGEON TRIED TO ATTACH THE INSERTION HANDLE TO A HINDFOOT ARTHRODESIS NAIL USING THE CONNECTING SCREW, BUT IT WAS VERY DIFFICULT TO ALIGN THE INSERTION HANDLE WITH THE NAIL. THE INSERTION HANDLE WAS DAMAGED, BUT THE SURGEON EVENTUALLY GOT THE NAIL AND HANDLE CONNECTED. SURGERY WAS DELAYED FOR 3 MINUTES, THERE WAS NO REPORTED ADVERSE PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242021 ↗
• MalfunctionMay 16, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2022, THE PINS OF THE TARGET BRACKET COULD ONLY BE INSERTED INTO THE GROOVES OF THE EXPERT BACKFOOT ARTHRODESIS WITH GREAT EFFORT. A PIN APPEARED BENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. PATIENT WAS LISTED AS GOOD. A 2 MINUTE SURGICAL DELAY WAS REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN INSERTION HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14409812 ↗
• MalfunctionNov 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON STRUGGLED TO SEAT THE TITANIUM HINDFOOT ARTHRODESIS CANNULATED NAIL ON TO INSERTION HANDLE. THE NAIL WAS EVENTUALLY ATTACHED BUT REQUIRED SOME FORCE. THE EVENT OCCURRED INTRA-OP BUT PRIOR TO INCISION. THE ADDITIONAL FORCE WAS APPLIED TO FULLY SEAT THE IMPLANT ON THE INSERTION HANDLE. THE CASE WAS NOT DELAYED IN ANY WAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895771 ↗
• MalfunctionSep 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021 DURING AN UNKNOWN PROCEDURE, THE INSERTION HANDLE, UNKNOWN DRILL BIT AND UNKNOWN NAIL WERE MISALIGNED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME WAS GOOD. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453898 ↗
• MalfunctionMay 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE T-CHUCK HANDLE DID NOT FUNCTION PROPERLY ANYMORE. THE HANDPIECE DETACHED FROM THE BODY OF THE INSTRUMENT. THE TWO CONNECTIONS OF THE AIMING DEVICE ARE DAMAGED. THE NOTCHES OF THE NAIL DID NOT FIT INTO THE TWO PROTRUSIONS OF THE AIMING DEVICE. NO PATIENT CONSEQUENCE OR IMPACT DURING THE SURGERY. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893100 ↗
• MalfunctionMar 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE CONNECTION SCREW AND NAIL DID NOT CONNECT PROPERLY TO THE AIMING ARM. A VISUAL INSPECTION OF THE AIMING ARM SHOWED SOME DEFORMATION ON THE INSIDE OF THE AIMING ARM. THERE WAS A SURGICAL DELAY OF ONE (1) HOUR. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485683 ↗
• MalfunctionDec 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HINDFOOT ARTHRODESIS NAIL SET - UNDERWENT TRAY AUDIT AND PREVENTATIVE MAINTENANCE. THE INSTRUMENTS REQUIRE REPLACEMENT AS THE ENTIRE AIMING ARM SEEMS TO BE MISSING THE NAIL DURING DRILLING/SCREW INSERTION. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101747 ↗
• MalfunctionFeb 26, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THIS COMPLAINT INVOLVES SIX (6) DEVICES.

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

  MAUDE report 9756173 ↗
• MalfunctionOct 17, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE INSERTION HANDLE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204699 ↗
• InjurySep 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A LEFT HINDFOOT ARTHRODESIS WITH NAIL PROCEDURE ON (B)(6) 2019, THE AIMING ARM ASSEMBLY MISALIGNED BOTH PROXIMAL SCREWS. THE SURGEON INSERTED A LEFT EXPERT HINDFOOT NAIL. IT WAS CONFIRMED THE NAIL WAS LOADED PROPERLY ONTO INSERTION HANDLE BY CONFIRMING THE BEND OF THE NAIL MATCHED THE ETCHED PICTURE ON THE INSERTION HANDLE. THE SURGEON ALSO TESTED THE AIMING ARM BEFORE INSERTION INTO PATIENT BY PUTTING THE TRIPLE TROCAR ASSEMBLY AND CORRESPONDING DRILL BIT THROUGH THE CORRESPONDING NAIL HOLES. WITH THE NAIL INSERTED AND THE AIMING ARM IN (P) POSITION, THE SURGEON INSERTED TWO (2) 6.0 MM SCREWS INTO THE CALCANEUS WITHOUT ISSUE. HE ALSO DRILLED AND INSERTED THE OBLIQUE 5.0 MM SCREW INTO THE TALUS WITHOUT ISSUE. WHEN THE SURGEON TRIED TO DRILL THROUGH THE (TWO) 2 (CORRECT) PROXIMAL HOLES LABELLED (STATIC) AND (180) THE 4.2 MM DRILL BIT ENCOUNTERED THE NAIL ITSELF AND COULD NOT PASS THROUGH THE DESIGNATED NAIL HOLES. FOR THESE PROXIMAL SCREWS THE AIMING ARM SHOWED (M) IN THE WINDOW AS APPROPRIATE AND HE USED TRIPLE TROCAR ASSEMBLY WITH DRILL BIT, WHICH WERE THE SAME ITEMS HE HAD USED FOR THE TALAR

  Patient problems: Injury; No Code Available

  MAUDE report 9118424 ↗
• MalfunctionMar 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING HIND FOOT NAIL PROCEDURE ON (B)(6) 2019, THE CONNECTION BETWEEN AN UNKNOWN NAIL AND AN INSERTION HANDLE FOR HIND FOOT NAIL WAS FOUND TO BE WORN OUT. THE NAIL WAS ONLY JUST ABOUT SEATED CORRECTLY. AS PER SURGEON, IF IT WEARS MUCH MORE THERE MAY BE A INCIDENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 2-3 MINUTES SURGICAL DELAY WITH NO HARM REPORTED TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN HIND FOOT NAIL (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8400361 ↗
• MalfunctionOct 26, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF THE DEVICES ON AN UNKNOWN DATE, IT WAS NOTED THAT THE INSERTION HANDLE FOR HINDFOOT ARTHODESIS NAIL AND THE NAIL DID NOT SEEM TIGHT WHEN PUT TOGETHER. IT IS NOT KNOWN IF THE CONNECTING SCREW OR THE PRONGS OF THE INSERTION HANDLE ARE DAMAGED, AS IT WAS THE INSERTION HANDLE THAT SEEMED TO HAVE A LITTLE PLAY. THERE WAS NO PATIENT OR SURGICAL PROCEDURE INVOLVEMENT. CONCOMITANT DEVICES: CANNULATED SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), HINDFOOT ARTHODESIS NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR HINDFOOT ARTHRODESIS NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8009080 ↗
• MalfunctionJul 9, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HINDFOOT NAIL ARTHRODESIS CASE AND FOOT SURGERY ON (B)(6) 2018. DURING THE PROCEDURE, THE AIMING ARM AND INSERTION HANDLE WERE BEING USED IN THE HINDFOOT FUSION CASE, AND THE AIMING ARM AND INSERTION HANDLE MISSED THE PROXIMAL LOCKING HOLES IN THE NAIL DURING PROXIMAL LOCKING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7671091 ↗
• MalfunctionNov 29, 2017Failure to Align; Failure to Align

  IT WAS REPORTED DURING AN ANKLE FUSION PROCEDURE FOR A LEFT HINDFOOT ARTHRODESIS ON (B)(6) 2017, THE SURGEON ATTEMPTED TO INSERT TWO DRILL BITS VIA 2 DIFFERENT HOLES OF THE AIMING ARM AND THEY KEPT HITTING THE NAIL. THEY SEEMED TO BE MISALIGNED WITH THE AIMING ARM OR THE INSERTION HANDLE, BUT THE SURGEON FELT HE HAD ENOUGH ROOM AND WAS ABLE TO CREATE THE HOLE FOR THE SCREWS. THIS HAPPENED IN SEVERAL SCREW HOLES. UPON SCREW INSERTION, SURGEON WAS ABLE TO MANIPULATE THE DRILL TO GET THE SCREWS IN THE HOLES SUCCESSFULLY. THERE WAS A TWO MINUTES DELAY JUST TO REALIGN THE DRILL. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO MEDICAL INTERVENTION REQUIRED. PATIENT STATUS FOLLOWING SURGERY WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), TROCAR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), CANNULATED CONNECTING SCREW (PART# 03.010.146, LOT# U225004, QUANTITY 1), THREADED ALIGNMENT PIN (PART# 03.008.004, LOT# 1733002, QUANTITY 1), PROTECTION SLEEVE (PART# 03.010.063, LOT# 1939259, QUANTITY 1), DRILL SLEEVE (PART# 03.010.065, LOT# 1593330, QUANTITY 1), DRILL SLEEVE (PART# 03.010.066, LOT# 3436603, QUANTITY 1). THIS REPORT IS FOR ONE (1) INSE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068323 ↗
• MalfunctionAug 28, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT AN INSERTION HANDLE, AIMING ARM AND CANNULATED CONNECTING SCREW FOR PERCUTANEOUS INSERTION HANDLE WERE INSTRUMENTAL IN A SCREW NOT ALIGNING WITH A NAIL ON (B)(6) 2017. THIS MISALIGNMENT OCCURRED DURING A HINDFOOT FUSION PROCEDURE LEADING TO A MINUTE SURGICAL DELAY. AN X-RAY (UNAVAILABLE) WAS TAKEN DUE TO THE MISALIGNMENT. ANOTHER SET OF INSTRUMENTS WAS READILY AVAILABLE AND PROCEDURE WAS SUCCESSFUL WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT IS FOR THREE (3) DEVICES. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1); UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1). THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6825741 ↗
• MalfunctionJul 31, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED UPON RECEIPT OF A LOANER SET FROM THE DISTRIBUTOR IT WAS NOTED THE INSERTION HANDLE FOR HINDFOOT ARTHRODESIS NAIL-EX HAD ONE TOOTH BROKEN OFF AND ANOTHER IS BENT AND DEFORMED. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR HINDFOOT ARTHRODESIS NAIL-EX THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6755294 ↗
• MalfunctionJun 29, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE CONNECTION BETWEEN THE AIMING ARM AND INSERTION HANDLE SEEMED TO BE LOOSE, WHICH RESULTED IN THE DRILL GUIDES NOT PROJECTING THE DRILL THROUGH THE NAIL PROPERLY DURING A PROCEDURE ON (B)(6) 2017. THIS DELAYED THE CASE (3-5) MINUTES. NO FRAGMENTS WERE CREATED BY THE ISSUE, SO NO FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS NO NEED FOR INCREASED X-RAY DURING THE PROCEDURE DUE TO THE ISSUE. THE TREATMENT WAS SUCCESSFULLY COMPLETED WITH NO FURTHER ISSUE. THERE ARE TWO DEVICES INVOLVED IN THIS COMPLAINT. REPORTED CONCOMITANT PARTS: UNKNOWN DRILL GUIDE (PART # UNKNOWN, LOT # UNKNOWN, QTY. 1). UNKNOWN INTRAMEDULLARY NAIL: PART # UNKNOWN, LOT # UNKNOWN, QTY. 1). THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6679167 ↗