NA 03.010.441Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886982068835), received between Feb 22, 2017 and Jun 2, 2023 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (17 reports).

1 other recall cover devices cleared under the same FDA submission (K111667); they may or may not involve this specific model.

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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2023Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN SUPRAPATELLAR EXPERT TIBIAL NAIL PROCEDURE ON (B)(6) 2023, THE AIMING ARM WAS NOTICED TO BE BROKEN. THE CASE WAS ABLE TO BE COMPLETED USING THE ADVANCED NAILING INSTRUMENTS. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR AN AIMING ARM FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050189 ↗
• MalfunctionJan 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, INSERTION HANDLE WAS NOT FITTING WITH AIMING ARM. NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16266325 ↗
• MalfunctionSep 20, 2022Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SURGEON WAS TRYING TO MOVE THE NAIL MORE DISTALLY BY STRIKING THE DRIVING CAP WITH THE MALLET. THE AIMING ARM CAUGHT ON THE SUPRAPATELLAR NAIL TROCAR AND BROKE. THERE WAS A 5 MINUTE SURGICAL DELAY. ANOTHER SET WAS OPENED AND USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) AIMING ARM FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454349 ↗
• MalfunctionFeb 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS PERFORMING A SUPRAPATELLAR TIBIAL NAIL AND HAD ISSUES WITH THE AIMING ARM, NOT HARDENING AND DURING THE PROCESS, WHILE REMOVING THE UNKNOWN COUPLING BOLT, THE TIBIAL NAIL WAS STRIPPED TWO (2) ENDCAPS FOR TIBIAL NAIL WERE DAMAGED. I DON¿T HAVE A LOT NUMBERS THEY WERE DISCARDED. THREE ITEMS NEED TO BE REPLACED, DURING THIS PROCESS THE AIMING ARM, UNKNOWN INSTRUMENT, AND COUPLING BOLT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416120 ↗
• MalfunctionSep 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2021, THE INSERTION HANDLE FOR SUPRAPATELLAR BECAME WARPED AND WILL NOT DETACH FROM THE RUE AIMING ARM FOR SUPRAPATELLAR. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO OTHER MEDICAL INTERVENTION. THIS REPORT IS FOR ONE (1) AIMING ARM FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460767 ↗
• MalfunctionAug 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, WHILE DRILLING THE PROXIMAL SCREW THE DRILL BIT HIT THE NAIL. THE SURGEON WAS ABLE TO TARGET THE HOLE AND THE SCREW WAS ACCURATELY PLACED. CHECKED POSTOPERATIVE AND IT WAS NOTED THAT THE HOLES IN THE GUIDE LINE UP WITH THE HOLES IN THE TIBIAL NAILS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) AIMING ARM FOR SUPRAPATELLAR THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288953 ↗
• MalfunctionJul 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN INTRAMEDULLARY RODDING OF A TIBIA, IT WAS DISCOVERED THAT ATTACHMENT OF THE DEPUY SYNTHES SUPRAPATELLAR AIMING ARM WAS DIFFICULT TO ATTACH TO THE CORRESPONDING INSERTION HANDLE INTRA-OPERATIVELY. A MALLET WAS REQUIRED TO SEAT THE AIMING DEVICE APPROPRIATELY TO THE INSERTION HANDLE. UPON INSPECTION, IT APPEARS THE DOWELS ON THE AIMING ARM ARE OUT OF ALIGNMENT. THERE WAS NO SURGICAL DELAY. THE CASE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN AIMING ARM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256469 ↗
• MalfunctionJul 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, WHILE REAMING A SUPRAPATELLAR TIBIAL NAIL, THERE WAS DIFFICULTY TO CATCHING THE FLEXIBLE REAMERS ON THE PROTECTION SLEEVE WHEN RETRACTING FLEXIBLE REAMER. FURTHERMORE, WHEN DRILLING FOR THE S1 PROXIMAL INTERLOCKING SCREW, THE DRILL BIT WOULD NOT PASS THROUGH THE NAIL AND UNABLE TO PLACE A SCREW THROUGH THE DESIRED HOLE. THE S2 PROXIMAL INTERLOCKING SCREW WAS SUCCESSFULLY DRILLED AND INSERTED ALONG WITH ANOTHER PROXIMAL OBLIQUE SCREW. THERE WAS 10 MINUTES OF SURGICAL DELAY NOTED. NO FRAGMENTS GENERATED NOTED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNK - INSERTION INSTRUMENTS: TRAUMA :PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). UNK - REAMING RODS :PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) AIMING ARM FOR SUPRAPATELLAR. THIS REPORT IS 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188922 ↗
• MalfunctionJun 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHEN THE SURGEON WAS INSTALLING A TIBIA NAIL USING OUR SUPRAPATELLAR TIBIA NAILING SYSTEM, UNABLE TO GET THE PROXIMAL LOCKING SCREWS THROUGH THE NAIL USING THE AIMING ARM AND THE DEVICES MAY BE OUT OF ALIGNMENT. IT IS UNKNOWN IF FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN), UNK - NAILS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) AIMING ARM FOR SUPRAPATELLAR. THIS REPORT IS 2 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12004716 ↗
• MalfunctionApr 6, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE WHILE INSERTING THE NAIL, CARBON FIBER TIBIAL NAIL JIG BROKE. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED AND IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNKNOWN TIBIAL NAIL (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY:1), UNKNOWN INSERTION HANDLE (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY:1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) AIMING ARM FOR SUPRAPATELLAR. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624708 ↗
• MalfunctionDec 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, WHILE DRILLING, THE SURGEON HIT THE NAIL AND DEVICES (INSERTION HANDLE, CANNULATED SCREW, PROTECTION SLEEVE, DRILL SLEEVE, AIMING ARM FOR SUPRATELLAR, TITANIUM CANNULATED TIBIAL NAIL, AND DRILL BIT) DID NOT LINE UP COMPLETELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11078246 ↗
• MalfunctionDec 16, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE DRIVING CAP BROKE OFF INSIDE THE INSERTION HANDLE AND THE AIMING ARM FELL ON THE FLOOR AND BROKE OFF. THE FLEXIBLE SHAFT HAS MALFUNCTIONED, AND THE UNKNOWN REAMER HEAD BROKE OFF INTO THE PATIENT. THE SURGEON USED A BACKUP SET TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE FRAGMENTS OF THE BROKEN DEVICE WERE GENERATED. CONCOMITANT DEVICES REPORTED: 5.0MM FLEXIBLE SHAFT 620MM (PART NUMBER 352.044, LOT UNKNOWN, QUANTITY 1), DRIVING CAP (PART NUMBER 03.010.475, LOT UNKNOWN, QUANTITY 1), INSERTION HANDLE FOR SUPRAPATELLAR (PART NUMBER 03.010.440, LOT UNKNOWN, QUANTITY 1), IMPACTION INSTRUMENTS: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), REAMERS: REAMER HEAD (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 AIMING ARM FOR SUPRAPATELLAR. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023084 ↗
• MalfunctionDec 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN EXPERT TIBIAL NAIL INSERTION PROCEDURE ON (B)(6) 2020, THE DRILL BIT MADE CONTACT WITH NAIL WHILE DRILLING FOR THE PROXIMAL SCREW. THE DEVICE WAS CHECKED AFTER THE PROCEDURE AND SHOWED EVERYTHING WAS CORRECTLY ALIGNED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 2 MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR 1 AIMING ARM FOR SUPRAPATELLAR. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10943379 ↗
• MalfunctionNov 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, 1 INSERTION HANDLE FOR SUPRAPATELLAR,1 AIMING ARM FOR SUPRAPATELLAR AND 1 CANNULATED CONNECTING SCREW WERE UNABLE TO TARGET THE UNKNOWN PROXIMAL LOCKING SCREW. THE UNKNOWN CONNECTING SCREW WAS IMPARTIAL INTO THE HANDLE AND VERY DIFFICULT TO REMOVE. THERE WAS A 30 MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS SUCCESSFUL. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR 1 AIMING ARM FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10870083 ↗
• MalfunctionNov 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SUPRAPATELLAR NAILING ON (B)(6) 2020, PART OF THE PROTECTION SLEEVE WAS EITHER REAMED OR CUT. THE SURGEON NEEDED TO OPEN THE PATIENT FURTHER TO RETRIEVE THE PIECE. IT WAS ALSO REPORTED THAT THE SCREW MISSED THE NAIL THROUGH THE AIMING ARM. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF THIRTY (30) MINUTES. PATIENT STATUS WAS VERY GOOD. THIS REPORT IS FOR A AIMING ARM FOR SUPRAPATELLAR. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10820507 ↗
• MalfunctionJul 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, DURING DRILLING FOR PROXIMAL UNKNOWN SCREWS, THE DRILL BIT WAS CONTACTED NAIL AND WITH AN UNKNOWN ISSUE. THE SURGEON SUCCESSFULLY PASSED THE UNKNOWN SCREW AND AFTER THE SURGERY, THE GUIDE/ DRILL SLEEVE LINED UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) AIMING ARM FOR SUPRAPATELLAR. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286027 ↗
• MalfunctionMay 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING THE INSERTION OF A TIBIA NAIL AND PROXIMAL INTERLOCK THERE WAS DIFFICULTY SCREWING THE AIMING ARM FOR SUPRAPATELLAR UNTO THE INSERTION HANDLE FOR SUPRAPATELLAR. THE AIMING ARM FELT STRIPPED. THE AIMING ARM WAS EVENTUALLY SCREWED ON AND WAS USED IN THE PROCEDURE. REMOVAL OF THE AIMING ARM WAS ALMOST IMPOSSIBLE, WHICH CAUSED THE SURGEON TO MEASURE THE TI LOCKING SCREW THROUGH THE AIMING ARM. THE LOCKING SCREW MEASURED TOO SHORT AND COULD NOT BE USED. ANOTHER LONGER, UNKNOWN SCREW WAS USED INSTEAD. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM F/IM NAIL-STER (PART NUMBER 04.005.516S, LOT 3L20002, QUANTITY 1), INSERTION HANDLE FOR SUPRAPATELLAR (PART NUMBER 03.010.440, LOT 170472-101, QUANTITY 1). THIS REPORT INVOLVES ONE (1) AIMING ARM FOR SUPRAPATELLAR. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10100761 ↗
• MalfunctionMar 30, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, WHILE THE SURGEON WAS USING THE AIMING ARM FOR SUPRAPATELLAR FOR PROXIMAL INTERLOCKS ON AN EXPERT TIBIAL NAIL, THE DRILL MISSED THE LOCKING HOLE THROUGH THE TARGETED GUIDE AND HIT THE NAIL. THE GUIDE AND DRILL WERE REMOVED BY UTILIZING THE PERFECT CIRCLES TECHNIQUE. SURGICAL DELAY AND PROCEDURE OUTCOME ARE UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: CANN CONNECTIONS SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX(PART NUMBER 03.010.404, LOT U261953, QUANTITY 1), INSERTION HANDLE SUPRAPATELLAR(PART NUMBER 03.010.440, LOT 180183-101, QUANTITY 1), DRILL BITS: TRAUMA (UNKNOWN PART NUMBER, UNKNOWN LOT, QUANTITY 1), NAILS (UNKNOWN PART NUMBER, UNKNOWN LOT, QUANTITY 1). THIS REPORT INVOLVES ONE (1) AIMING ARM FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9899661 ↗
• MalfunctionApr 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INSERTION OF PROXIMAL SCREWS IN A TIBIA NAIL, THE SURGEON NOTED THAT THE DRILL BIT MADE CONTACT WITH THE NAIL. HOWEVER, DRILL WENT THROUGH AND WAS ABLE PLACE SCREW. UPON EXAMINATION, IT WAS NOTED THAT THE AIMING DEVICE LINED UP. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. NO FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE: LOCKING SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546290 ↗
• MalfunctionFeb 8, 2019Failure to Align; Failure to Align

  CONCOMITANT DEVICE REPORTED: UNKNOWN- NAIL: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8321776 ↗
• MalfunctionOct 24, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, THE PROTECTION SLEEVE AND THE DRILL SLEEVE DID NOT ALIGN PROPERLY WITH THE NAIL. AS A RESULT, SCREW HOLES WERE DRILLED FREE HANDED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. CONCOMITANT DEVICE: NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999192 ↗
• MalfunctionOct 24, 2018Device-Device Incompatibility; Device-Device Incompatibility

  UPDATE 12/04/2018: ADDING THE CONCOMITANT PART; IT WAS REPORTED THAT THERE WAS A DRILL USED WITH NO ALLEGATIONS. MODIFIED EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A PROCEDURE TO IMPLANT A CANNULATED TIBIAL NAIL ON (B)(6) 2018, WHILE DRILLING FOR THE CANNULATED CONNECTING SCREW ON THE PROXIMAL PORTION OF THE NAIL, SURGEON HAD TO SHAKE THE DRILL SO THE DRILL BIT TO PASS THROUGH THE NAIL. THE AIMING ARM, INSERTION HANDLE, DRILL SLEEVE, AND PROTECTION SLEEVE WERE REPORTED TO HAVE CONTRIBUTED TO THE ALIGNMENT DIFFICULTY. NO DEVICES WERE BROKEN BUT THE NAIL WAS HIT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) . THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7998720 ↗
• MalfunctionOct 22, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, WHILE DRILLING THROUGH THE AIMING ARM USING THE SUPRA PATELLAR INSERTION HANDLE, THE CALIBRATED THREE-FLUTED DRILL BIT MISSED THE STATIC TRANSVERSE HOLE IN THE TITANIUM CANNULATED TIBIAL NAIL. IT WAS MEANT TO MATCH UP WITH THE APPLIED PHYSICAL DEFORMATION TO THE INSERTION HANDLE/AIMING ARM CONSTRUCT IN ORDER TO ACHIEVE CORRECT ALIGNMENT WHICH ALLOWED THE DRILL BIT TO PASS THROUGH THE NAIL AS DESIRED. IT WAS FURTHER NOTED THAT THE WHOLE CONSTRUCT: INSERTION HANDLE, AIMING GUIDE, AND DRILL SLEEVES ALLOW FOR ENOUGH PLAY THAT CERTAIN PATIENTS' BONE/TISSUE DEFORM THE CONSTRUCT ENOUGH TO CREATE MISALIGNMENT. FOLLOWING THIS, THE TITANIUM LOCKING SCREW WAS INSERTED AS INTENDED WITHOUT FURTHER INCIDENT. NO FURTHER INCIDENT BUT THE INITIAL PART OF THE DRILL BIT DID NOT GO TO THE NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: TITANIUM LOCKING SCREW (PART: 04.005.428S, LOT: UNKNOWN, QUANTITY: 1), TITANIUM CANNULATED TIBIAL NAIL (PART: 04.034.349S, LOT: UNKNOWN, QUANTITY:1) THIS REPORT IS FOR ONE (1) AIMING ARM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7992753 ↗
• MalfunctionFeb 13, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL TIBIA THE SURGEON HAD DIFFICULTY INSERTING THE COUPLING SCREW INTO THE NAIL AS THE INSTRUMENTATION SEEMED TO BE MISALIGNED. IT WAS FURTHER EXPLAINED THAT THE SURGEON HAD INSERTED THE NAIL DOWN THE LENGTH OF THE PATIENT BONE, HAD ASSEMBLED THE INSTRUMENTATION AND MADE THE INCISION BUT THE AIMING ARM WAS NOT ALIGNED WITH THE NAIL AS EXPECTED. THE SURGEON FLEXED THE PATIENT KNEE AS THE PATIENT KNEE WAS HYPEREXTENDED AND IN THE PAST FLEXING THE KNEE 5 - 10 DEGREES USUALLY ADDRESSES ANY ISSUE WITH MISALIGNMENT. THE MISALIGNMENT WAS NOT ADDRESSED, SO THE SURGEON DISMANTLED THE AIMING ARM, THE DRILL SLEEVE, THE TROCAR SLEEVE, AND THE OUTER SLEEVE. THE SURGEON, NOT WANTING TO MAKE AN ADDITIONAL INCISION, TOOK ADDITIONAL X-RAYS AND USED THE "PERFECT CIRCLE TECHNIQUE" TO FREE-HAND THE PLACEMENT OF THE CONNECTING SCREW. THIS LEAD TO ADDITIONAL X-RAY EXPOSURE TO THE PATIENT AS QUITE A BIT MORE X-RAYS WERE REQUIRED TO ASSIST WITH THE FREE-HAND TECHNIQUE PERFORMED BY THE SURGEON. IT WAS REPORTED THAT THE SURGEON IS VERY SKILLED USING THE PERFECT CIRCLE APPROACH SO THERE WAS ONLY A THREE-MINUTE DELAY IN THE PROCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7268640 ↗
• MalfunctionJul 24, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A NAILING OF A TIBIAL SHAFT WHILE DRILLING THROUGH THE GUIDE THE DRILL TIP WAS NOT GOING THROUGH THE LOCKING HOLES OF THE NAIL AND WAS HITTING THE NAIL DIRECTLY. THE NAIL WAS PULLED OUT TO MAKE SURE EVERYTHING ALIGNED PROPERLY. IT APPEARED TO LINE UP PROPERLY AND WAS PLACED BACK IN THE PATIENT BUT THE DRILL BIT WAS STILL HITTING THE NAIL. THE SURGEON DECIDED TO APPLY PRESSURE TO THE AIMING ARM AND MOVE IT AROUND, AT THAT POINT THE DRILL BIT WAS ABLE TO GO THROUGH THE LOCKING HOLES. THIS CAUSED A 5-10 MINUTE SURGICAL DELAY. THERE WAS NO REPORT OF PATIENT HARM AND SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: CONNECTING SCREW (PART # 03.010.404, LOT # U205159, QUANTITY 1),NAIL (PART # 04.004.446S, LOT# UNKNOWN, QUANTITY 1), DRILL BIT (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6736824 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111667. One submission often covers many models, so check the product and lot details in each record.

• Z-0404-2014 · Oct 14, 2013 · Terminated
  Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabil