NA 03.010.052Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886982067241), received between May 10, 2017 and Sep 2, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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.

• MalfunctionSep 2, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571431 ↗
• MalfunctionFeb 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE ARC INSER P/EXPERT TN P/APPROACH SUPRA DOES NOT ENTER THE DIRECTIONAL ARM EASILY; IT IS POSSIBLE TO ATTACH THESE TWO PIECES IN SURGERY BUT NOT DISARM THEM LATER; UNITS ARE LEFT; IT IS NOT POSSIBLE TO IDENTIFY WHICH OF THE TWO PIECES HAS THE PROBLEM; REVIEW. THE SURGEON MAKES THE SUGGESTION TO SEND AT LEAST 3 WATER GUIDES (3.2 L400). IT HAS NO INVOLVEMENT WITH THE PATIENT. THIS REPORT IS FOR ONE (1)AIM-ARM F/TIB NAIL THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658497 ↗
• MalfunctionJan 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON DEC 17, 2023, A TIBIAL NAIL AIMING ARM WAS NOT LINING UP PROPERLY WITH THE SCREW HOLES IN THE NAIL. THE SURGEONS WERE ABLE TO ¿FREE HAND¿ LOCK THE NAIL AND COMPLETE THE PROCEDURE WITHOUT DELAY OR INCIDENT TO THE PATIENT. NO PATIENT INFO AVAILABLE. THIS REPORT IS FOR ONE (1) AIM-ARM F/TIB NAIL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491221 ↗
• MalfunctionJan 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, AT THE TIME OF FINISHING THE PROCEDURE, BENDING OF THE PROXIMAL PART OF THE NAIL WAS OBSERVED. IT WAS NOTED WHEN RELEASING THE CONNECTION SCREW THERE WAS BINDING, MAKING IT ALMOST IMPOSSIBLE TO REMOVE THE SCREW. THERE WAS DISCOMFORT FROM THE SPECIALIST, THE PROCEDURE WAS ACHIEVED WITH SUCCESS; HOWEVER, THE NAIL BENDING WAS NOT RESOLVED. THERE WAS AN ADDITIONAL SURGERY TIME OF 20 MINUTES APPROXIMATELY WITH ALL THE NOVELTIES PRESENTED DURING THE PROCEDURE, THERE WAS NO INVOLVEMENT OF THE PATIENT. THIS REPORT INVOLVES ONE (1) AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435373 ↗
• MalfunctionDec 20, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2023, THE FOLLOWING DEVICES WERE BROKEN: 1 HAND-REAMER F/MEDULL-CANAL Ø6 1 SYNREAM REAMER HEAD Ø8.5 1 DRILL BIT 3.2 CALIBR L145 3FLUTE F/QUIC 1 AIM-ARM F/TIB NAIL 1 INSERT-HANDLE F/ETN F/SUPRAPAT APPROACH NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) AIM-ARM F/TIB NAIL THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18369875 ↗
• MalfunctionApr 5, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PIECE OF THE AIMING ARM FOR THE EXPERT TIBIA NAIL WAS BENT AND DIDN¿T HOLD ACCURATELY ON THE INSERTION HANDLE. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681039 ↗
• MalfunctionJul 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TROCARS WOULD NOT SLIDE INTO THE AIMING ARM¿S HOLES PROPERLY. THE AIMING ARM COULD NOT BE USED PROPERLY TO INSERT SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR AN AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085247 ↗
• MalfunctionApr 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022 THAT THE KNOB THAT TIGHTENS THE AIMING ARM FOR TI CANN TIBIAL NAIL-EX TO THE INSERTION HANDLE TIBIAL NAIL-EX INSERTION HANDLE BROKE OFF FROM THE ACTUAL BOLT DURING AN EX TIBIA NAIL PROCEDURE. THE SURGEON ALSO ATTEMPTED TO REMOVE THE BOLT FROM THE AIMING ARM SO THAT WE COULD USE A TIGHTENING KNOB FROM A RAFN SET HOWEVER THE BOLT BECAME CROSS THREADED AND COULD NOT BE REMOVED FROM THE AIMING ARM. THE DOCTOR WAS ABLE TO USE TWO LOBSTER CLAWS TO TIGHTEN THE AIMING ARM TO THE INSERTION HANDLE FOR THE INSERTION OF THE PROXIMAL LOCKING SCREWS AND COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF 10 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE.. THIS REPORT IS FOR ONE (1) 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246154 ↗
• MalfunctionSep 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A PROCEDURE WITH PROXIMAL INTERLOCK SCREWS FOR A TIBIAL NAIL, THE AIMING ARM AND INSERTION HANDLE, WHEN INSTALLED CORRECTLY TO THE NAIL, DID NOT LINE UP WITH THE SLEEVES. THIS MISALIGNMENT DID NOT ALLOW THE APPROPRIATE DRILL BIT TO PASS THROUGH THE NAIL AFTER IT WAS INSERTED INTO THE BODY. IT WAS MENTIONED THAT THE PARTS MIGHT BE WEARING OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY SLIGHTLY FLEXING THE DEVICE. THERE WAS A ONE (1) MINUTE SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: STANDARD INSERTION HANDLE (PART NUMBER 03.010.045, LOT 1620767, QUANTITY 1), NAILS: TIBIAL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). GUIDES/SLEEVES/AIMING: SLEEVE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), DRILL BITS: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), INSERTION INSTRUMENTS: CONNECTING/COUPLING SCREW: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN QUANTITY 1). THIS REPORT INVOLVES ONE (1) AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10573512 ↗
• MalfunctionSep 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN EXPERT TIBIAL NAIL CASE THE NAIL WAS ATTACHED TO THE STANDARD HANDLE AND THE AIMING ARM WAS ATTACHED AND TESTED PRIOR TO NAIL INSERTION, THE AIMING ARM HOLES DID NOT LINE UP WITH THE NAIL. A SECOND SET WAS OPENED AND THE NEW AIMING ARM WAS ATTACHED AND TESTED WITH HOLES LINING UP. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN NAIL INSERTION HANDLES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515232 ↗
• MalfunctionAug 25, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN INTRAMEDULLARY NAILING SYSTEM OF THE PROXIMAL TIBIA FRACTURE, WHEN THE SURGEON ATTEMPTED TO PLACE AN ANTERIOR TO POSTERIOR UNKNOWN SCREW IN AN UNKNOWN TIBIAL NAIL, THE AIMING ARM FOR TITANIUM CANNULATED TIBIAL NAIL WOULD NOT ACCEPT CANNULAS. DIFFERENT UNKNOWN PROXIMAL SCREWS WERE SELECTED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN INSERTION HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448326 ↗
• MalfunctionJan 10, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS FOUND OUT BY THE STERILE PROCESSING DEPARTMENT (SPD) THAT THE BLACK KNOB ON THE AIMING ARM FOR THE EX TIBIA NAIL SET HAD COME OFF. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION ON (B)(6) 2020 OF THE RETURNED AIMING, IT WAS REVEALED THAT THE THUMB SCREW'S DOWEL PIN COMPONENT HAD BROKEN/SHEARED OFF FLUSH WITH THE SURFACE OF THE KNOB'S SHAFT COMPONENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9577018 ↗
• MalfunctionSep 12, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE AIMING ARM FOR TITANIUM CANNULATED TIBIAL NAILS IS DEFORMED, THE TRIPLE SLEEVE WILL NOT FIT THROUGH THE HOLE. AN AIMING ARM FROM A DIFFERENT TIBIAL NAIL SET WAS USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: PROTECTION SLEEVE (PART # 03.010.063; LOT # UNKNOWN; QUANTITY 1), DRILL SLEEVE (PART # 03.010.064; LOT # UNKNOWN; QUANTITY 1), TROCAR (PART # 03.010.069; LOT # UNKNOWN; QUANTITY 1), UNKNOWN NAIL INSERTION HANDLE (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY 1), UNKNOWN NAIL (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM FOR TITANIUM CANNULATED TIBIAL NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9011359 ↗
• MalfunctionJul 24, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8821973 ↗
• MalfunctionJul 2, 2019Failure to Align; Device-Device Incompatibility; Failure to Align; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, WHEN INSERTING THE MEDIAL TO LATERAL PROXIMAL TRANSVERSE LOCKING SCREWS, AFTER DRILL PASSED NEAR CORTEX IT HIT THE NAIL AND NO LONGER ADVANCED. AT THAT MOMENT THE SURGEON STOPPED DRILLING, REMOVED DRILL BIT FROM GUIDE AND PROCEEDED TO RETIGHTEN THE CONNECTING SCREW OF INSERTION HANDLE AND NAIL, AND ALSO TIGHTENING THE AIMING ARM TO INSERTION HANDLE. BOTH WERE STILL TIGHT AND NO FURTHER TIGHTENING WAS ADDED. THE SPECIFIC ALLEGATION IS THAT THE AIMING ARM IS NOT ACCURATELY LINING UP WITH THE HOLES IN NAIL AT THE TRANSVERSE PROXIMAL END OF NAIL. THE SURGEON STATED THAT THIS WAS NOT THE FIRST TIME THAT THE MEDIAL TO LATERAL SCREW HAS HIT THE NAIL. HE REINSERTED DRILL BIT AND BEGAN DRILLING AGAIN. THE DRILL BIT CONTINUED TO HIT THE NAIL UNTIL THE SURGEON MOVED THE GUIDE WITH HIS HAND AND THEN DRILL BIT PASSED THROUGH THE NAIL. ONE LOCKING SCREW WAS INSERTED AND NOT REMOVED WITHOUT ANY INCIDENT. INSERTED OTHER PROXIMAL SCREWS IN THE PROXIMAL OBLIQUE HOLES WITHOUT ISSUE. NO BACKUP WAS USED DUE TO ONLY PUTTING ONE TRANSVERSE SCREW IN NAIL. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DELAY OF 3-5 MINUTES. PATIENT STATUS WAS GOOD. CONCOMITANT DEVICE REP

  Patient problems: No Patient Involvement

  MAUDE report 8755908 ↗
• MalfunctionMar 27, 2019Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THERE WAS AN AIMING ARM JIG FOR THE TIBIAL NAIL EXPERT THAT WAS NOT WORKING PROPERLY. THE UNKNOWN TIBIAL NAIL IMPLANT WAS FINE, BUT THE AIMING ARM FOR TITANIUM CANNULATED NAIL-EXPERT AND TIBIAL NAIL-EXPERT INSERTION HANDLE WAS BENT. THE TROCARS DID NOT LINE UP PROPERLY WITH THE NEW TIBIAL NAIL IMPLANT. THE OBLIQUE SCREWS WERE BEING PUT INTO THE TIBIAL NAIL THROUGH THE AIMING ARM AND THE TROCAR WOULD NOT PROPERLY LINE UP. THE SCREWS WERE NOT GOING THROUGH THE TIBIAL NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS REPORTED: UNKNOWN TIBIAL NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1); UNKNOWN OBLIQUE SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455382 ↗
• MalfunctionOct 10, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE AIMING DEVICE HOLES ARE MISALIGNED TO THE NAILS HOLES. IT LOOKS LIKE THE AIMING ARM DEVICE IS OFFSET. THERE WAS NO PATIENT INVOLVEMENT THIS REPORT IS FOR ONE (1) AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7951735 ↗
• MalfunctionMay 15, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT A PROTECTION DRILL SLEEVE WOULD NOT ADVANCE INTO ANTERIOR AIMING ARM OF THE TIBIA NAIL. THE SURGEON BELIEVED THAT THE AIMING ARM MAY HAVE A BURR AND HE DID NOT USE THE ANTERIOR SCREW HOLE. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL INFORMATION PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7515462 ↗
• MalfunctionApr 4, 2018Failure to Align; Failure to Align

  (B)(6) REPORTED THAT DURING AN INTRAMEDULLARY RODDING ON (B)(6) 2018 FOR A TIBIAL FRACTURE, THE CENTRAL HOLE (ANTERIOR POSTERIOR HOLE) OF THE AIMING ARM WOULD NOT AIM PROPERLY. THE TROCAR SLEEVE ASSEMBLY (PROTECTION SLEEVE) WOULD LINE UP WITH THE HOLE OF THE TIBIAL EX NAIL. THERE WAS NO ISSUE WITH THE TROCAR, AS IT ALIGNED PROPERLY WITH THE OTHER HOLES ON THE AIMING ARM. OTHER HOLES ON THE AIMING ARM WERE USED AND PROPER ALIGNMENT OF THE TROCAR WITH THE NAIL WAS ACHIEVED. THE NAIL WAS SUCCESSFULLY IMPLANTED. THERE WAS NO SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS STANDARD FOR THE PROCEDURE WERE TAKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 12.0 MM/8.0 MM PROTECTION SLEEVE 188 MM (PART # 03.010.063, LOT # UNKNOWN, QUANTITY OF 1) AND TIBIAL NAIL EX (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396653 ↗
• MalfunctionFeb 27, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A TIBIA NAIL PLACEMENT ON (B)(6) 2018, AS THE SURGEON DRILLED FOR THE STATIC HOLE, HE HIT THE ALREADY IMPLANTED NAIL WITH THE DRILL BIT. REPORTEDLY THE NAIL (WITH THE LOCKING BOLT THREADED INTO IT) HAD BEEN PLACED DOWN THE LENGTH OF THE BONE AND THE AIMING ARM AND RADIOLUCENT HANDLE HAD BEEN ATTACHED TO ASSIST IN THE ALIGNMENT OF THE IMPLANTS. THE GUIDES WERE ALSO BEING USED AT THE TIME BUT REPORTEDLY SLID INTO EACH OTHER PERFECTLY. THE SURGEON SUSPECTED THAT THE AIMING ARM AND RADIOLUCENT HANDLE WERE CAUSING THE MISALIGNMENT. HE REMOVED THE AIMING ARM AND RADIOLUCENT HANDLE AND FREE-HANDED THE REST OF THE IMPLANT PLACEMENT. THERE WERE REPORTEDLY NO SURGICAL DELAYS AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. ONLY ROUTINE X-RAYS WERE REQUIRED DURING THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT STATUS WAS REPORTED TO BE "GOOD" AT THE END OF THE PROCEDURE. CONCOMITANT DEVICES REPORTED: 12.0 MM / 8.0 MM PROTECTION SLEEVE (PART 03.010.063, LOT NUMBER UNKNOWN, QUANTITY 1), RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS 100 MM (PART 03.010.065, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM FOR CANNULATED TIB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300594 ↗
• MalfunctionJan 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN AIMING ARM WOULD NOT SCREW ON CORRECTLY DURING AN INTRAMEDULLARY (IM) TIBIAL NAIL PROCEDURE ON (B)(6) 2017. THIS CAUSED MISALIGNMENT WITH THE NAIL. THE NAIL HAD BEEN INSERTED WHEN THE AIMING ARM WAS BEING USED TO DRILL PILOT HOLES. WHEN THE MISALIGNMENT WAS NOTICED, ANOTHER DEVICE WAS OBTAINED FROM ANOTHER TRAY. THERE WAS A REPORTED SURGICAL DELAY OF FIVE MINUTES TO OBTAIN ANOTHER DEVICE. NO ADDITIONAL MEDICAL INTERVENTION OR ADDITIONAL X-RAYS WERE REQUIRED. THE FINAL CONSTRUCT WAS AN IM TIBIAL NAIL AND SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 10 MM TI CANNULATED TIBIAL NAIL-EX/345 MM-STERILE (PART # 04.004.449S, LOT # UNKNOWN, QTY # 1). STANDARD INSERTION HANDLE (PART # 03.010.045, LOT # UNKNOWN, QTY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR THE AIMING ARM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7158001 ↗
• MalfunctionOct 3, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT ON 14-SEP-2017, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A TIBIA, THE TROCAR WAS TARGETED TO THE ANTEROPOSTERIOR (AP) HOLE ON THE NAIL. THE HOLE ON THE AIMING ARM DID NOT ALLOW THE TROCAR TO PASS THROUGH IT. ANOTHER HOLE ON THE AIMING ARM WAS SELECTED AND THREE (3) PROXIMAL SCREWS WERE INSERTED SUCCESSFULLY. NO ISSUES WERE FOUND WITH THE TROCAR ASSEMBLY. THERE WAS NO SURGICAL DELAY AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS COMPLAINT IS FOR ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: UNKNOWN OUTER DRILL SLEEVE (UNKNOWN PART NUMBER, UNKNOWN LOT NUMBER, QUANTITY 1), UNKNOWN TROCAR(UNKNOWN PART NUMBER, UNKNOWN LOT NUMBER, QUANTITY 1); UNKNOWN PROTECTION SLEEVE (UNKNOWN PART NUMBER, UNKNOWN LOT NUMBER, QUANTITY 1); UNKNOWN LOCKING SCREW (UNKNOWN PART NUMBER, UNKNOWN LOT NUMBER, QUANTITY 1); UNKNOWN INSERTION HANDLE (UNKNOWN PART NUMBER, UNKNOWN LOT NUMBER, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6911330 ↗
• MalfunctionSep 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION OF FIELD EQUIPMENT, IT WAS NOTED THE LOCKING HOLE ON THE AIMING ARM FOR CANNULATED TIBIAL NAILS-EX IS DAMAGED. THE TROCAR DOES NOT FIT IN THE ANTEROPOSTERIOR (A/P) LOCKING HOLE THROUGH THE AIMING ARM. IT IS NOT KNOWN WHEN THE EVENT OCCURRED. NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: TROCAR (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) AIMING ARM FOR CANNULATED TIBIAL NAILS-EX THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6888340 ↗
• InjuryAug 10, 2017Bent; Bent

  IT WAS REPORTED THAT ONE OF THE HOLES IN THE AIMING ARM FOR TITANIUM CANNULATED TIBIAL NAILS-EX WAS BLOCKED OR BENT AND DID NOT ALLOW THE AIMING BARREL TO PASS THROUGH DURING A TIBIAL NAIL INSERTION ON (B)(6) 2017. THERE WAS A 5 TO 10 MINUTE DELAY TO DECIDE HOW TO PROCEED. THE SURGERY WAS COMPLETED USING THE GUIDE; HOWEVER, ONE LESS SCREW WAS USED IN THE PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH PATIENT OUTCOME AS STABLE. CONCOMITANT PART: NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM FOR TITANIUM CANNULATED TIBIAL NAILS-EX.. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6784200 ↗
• MalfunctionJul 20, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A RIGHT TIBIA SHAFT FRACTURE, THE ALIGNMENT OF THE INSERTION HANDLE AND AIMING ARM WAS NOTED AS BEING SLIGHTLY OFF, THE DRILL BIT TO STRIKE THE NAIL AND PREVENTED THE SCREW FROM GOING INTO THE HOLE OF THE NAIL. THE DEVICES WERE VISIBLY NOT CENTERED ON THE PATIENT¿S LEG. THE MISALIGNMENT WAS SLIGHT WHICH ALLOWED THE SURGEON TO APPLY FORCE IN ORDER TO GET THE SCREW THROUGH THE HOLE OF THE NAIL. THERE WAS NO SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN AS STANDARD FOR THE PROCEDURE. THE SURGEON WAS SATISFIED WITH PLACEMENT OF THE NAIL AND SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 10MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE (PART 04.004.446S, LOT 9870686, QUANTITY 1); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS (PART 04.005.530, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM FOR CANNULATED TIBIA NAILS THIS IS REPORT 2 OF 2 FOR (B)(4)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6729881 ↗