NA 2351-0050Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07613327350210), received between Dec 18, 2018 and Nov 24, 2020 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Break” (27 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Dec 5, 2019Class IITerminated

   Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.

   Z-0780-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2020Fracture; Fracture

  AS REPORTED: "THE CONNECTING THREAD BETWEEN 2351-0050 AND 2351-0180 IS BROKEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896153 ↗
• MalfunctionMar 14, 2020Fracture; Fracture

  AS REPORTED: "T2 ALPHA TIBIA SPI OPERATION. AFTER REAMING DURING THE SLEEVE THE SURGEON DIDN¿T REMOVE THE INNER METAL SLEEVE BEFORE TRYING TO INSERT THE TIBIA NAIL. HE HAMMERED ON THE STRIKE PLATE TO INSERT THE NAIL. WHEN DISCOVERING THAT THERE WERE NOT ROOM FOR INSERTING THE NAIL THROUGH THE SLEEVE HE BACK SLASHED. THE DELTA STRIKE PLATE BROKE AT THE THREADS AND THE DISTAL PART COULDN¿T BE REMOVED. AFTER REMOVING THE METAL INNER SLEEVE THE NAIL WERE PLACED CORRECTLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9832778 ↗
• MalfunctionJan 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE THREAD BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9586874 ↗
• MalfunctionNov 27, 2019Fracture; Fracture

  THE STRIKE PLATE FOR THE T2 ALPHA BROKE WHILE HAMMERING THE NAIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9387507 ↗
• MalfunctionNov 15, 2019Fracture; Break; Fracture

  PRIMARY PROCEDURE, LEFT FEMUR. IT WAS REPORTED THAT UPON IMPACTION, THE T2 ALPHA STRIKE PLATE BROKE OFF WHERE THE THREADS CONNECT WITH THE TARGETING ARM. A T2 STRIKE PLATE (NON-ALPHA) WAS OBTAINED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5 MINUTES. THE REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9332566 ↗
• MalfunctionOct 3, 2019Break

  AS REPORTED: "DR. WAS IMPACTING THE T2 ALPHA GT NAIL, OVER THE BALLTIP GUIDEWIRE, INTO THE INTRAMEDULLARY CANAL OF THE PATIENT'S FEMUR. AS DR. CONTINUED TO IMPACT THE STRIKE PLATE TO ADVANCE THE NAIL INTO ITS FINAL POSITION, HE BACK-SLAPPED THE DELTA STRIKE PLATE (2351-0050) TO MOVE THE NAIL PROXIMALLY. AT THIS POINT, THE DELTA STRIKE PLATE SHEARED OFF THE GT NAIL ADAPTER. THE THREADS OF THE DELTA STRIKE PLATE REMAINED ENGAGED IN THE GT NAIL ADAPTER, AND THE BREAKING POINT APPEARS TO BE AT THE JUNCTION OF THE STRIKE PLATE THREADS AND THE STRIKE PLATE SHAFT. THEREAFTER, THE CASE CONTINUED AS NORMAL AND THERE WAS NO HARM DONE TO THE PATIENT AS A RESULT OF THE BREAKAGE. THERE WAS NOTHING UNUSUAL IN THE TECHNIQUE THE SURGEON USED TO IMPACT THE NAIL, OR THE BACKSLAPPING, INCLUDING HOW HARD THEY WERE HITTING THE STRIKE PLATE." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9153633 ↗
• MalfunctionSep 24, 2019Break; Fracture; Fracture

  THE CUSTOMER REPORTED THAT WHILE INSERTING THE NAIL, THE IMPACTOR SHEARED OFF LEAVING THE THREADED END IN THE NAIL ADAPTOR. THE CASE WAS COMPLETED USING OTHER INSTRUMENTATION ON THE SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9108828 ↗
• MalfunctionSep 17, 2019Break; Fracture; Fracture

  AS REPORTED: "PRIMARY PROCEDURE TO ADDRESS A LEFT FEMORAL FRACTURE WITH THE T2 ALPHA GT NAIL. IT WAS REPORTED THAT ON IMPACTION, THE STRIKE PLATE BROKE AT THE JUNCTION WITH THE INSERTION HANDLE (THE THREADS OF THE STRIKE PLATE REMAINED IN THE INSERTION HANDLE). THE STRIKE PLATE HIT THE SURGEON IN THE FACE, CAUSING A SMALL LACERATION (NO STITCHES REQUIRED). CASE WAS COMPLETED BY IMPACTING DIRECTLY ON THE INSERTION HANDLE. SURGICAL DELAY WAS APPROXIMATELY 1 MINUTE." THE PROCEDURE WAS OTHERWISE COMPLETED SUCCESSFULLY.

  Patient problems: Injury; Laceration(s)

  MAUDE report 9079074 ↗
• MalfunctionSep 4, 2019Break; Detachment of Device or Device Component

  PRIMARY PROCEDURE, LEFT TIBIAL NAIL. IT WAS REPORTED THAT THE STRIKE PLATE WAS CORRECTLY THREADED INTO THE TARGETER. ON IMPACTION, THE THREADS OF THE STRIKE PLATE BROKE OFF IN THE ADAPTOR. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962947 ↗
• MalfunctionSep 4, 2019Break; Fracture; Material Split, Cut or Torn; Fracture

  DURING KNOCKING OUT A T2 ALPHA NAIL, THE COMBINED INSTRUMENTS WERE TORN OFF AT THE MIDDLE THREAD. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 5MIN. NOT LONGER. REP CONFIRMED THAT ONLY THE STRIKE PLATE WAS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962906 ↗
• MalfunctionSep 3, 2019Break

  AS REPORTED: "DURING AN INTERMEDULLARY NAIL CASE, THE STRIKE PLATE WAS STRIPPED OUT OF THE NAIL ADAPTER COMPLETELY WHILE ATTEMPTING TO BACKSLAP A NAIL OUT. A SECOND STRIKE PLATE WAS THEN USED IN ORDER TO RE-INSERT THE NAIL AND THIS STRIKE PLATE ALSO FAILED. NEITHER THE NAIL ADAPTER OR STRIKE PLATES WERE VIABLE AND WE HAD TO RESORT TO USING THE OLDER T2 SYSTEM. THIS DELAYED THE CASE AND ALSO ENDED UP IN WASTING THE FIRST NAIL".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8958122 ↗
• MalfunctionAug 29, 2019Break; Fracture; Detachment of Device or Device Component; Fracture

  A T2 ALPHA GT NAIL WAS BEING PLACED INTO A PATIENT. THE RESIDENT WAS HITTING THE STRIKE PLATE WHICH WAS THREADED ONTO THE TARGET. AT SOME POINT DURING THE INSERTION, THE RESIDENT STRUCK THE STRIKE PLATE AND IT SHEARED OFF AND HIT THE FLOOR. PART OF THE THREADS FROM THE STRIKE PLATE WERE STILL IN THE TARGET. THE NAIL WAS INSERTED SUCCESSFULLY AND NO ADVERSE EVENTS HAPPENED. NO SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8946680 ↗
• MalfunctionAug 23, 2019Break; Detachment of Device or Device Component

  T2 ALPHA IMPACTOR BROKE OFF IN THE SPI TIBIA GUIDE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8927319 ↗
• MalfunctionAug 20, 2019Break; Fracture; Failure to Advance; Fracture

  THE CUSTOMER REPORTED THAT DURING A CASE INVOLVING THE T2 ALPHA KIT, THE NAIL STRIKE PLATE THREADS BROKE OFF WITHIN THE NAIL JIG MAKING IT EXTREMELY DIFFICULT TO ADVANCE THE NAIL DOWN. ALL THREADS BROKE OFF WITHIN THE OUTER JIG, NOTHING FELL INTO THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER INSTRUMENT TO PUSH DOWN THE CONNECTING BOLT AND ADVANCE THE NAIL. THERE WAS A SURGICAL DELAY OF 5-10 MINUTES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8909752 ↗
• MalfunctionAug 20, 2019Break; Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE IMPACT OR EXTRACTOR HANDLE FOR T2 ALPHA WAS DAMAGED DURING SURGERY. THE NAIL WAS REMOVED AND THE SURGERY WAS COMPLETED WITH THE STANDARD RECON NAIL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF SURGICAL DELAY OR ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8909088 ↗
• MalfunctionAug 6, 2019Break; Fracture; Fracture

  AS REPORTED: "DOCTOR WAS IMPACTING THE T2 ALPHA TIBIA NAIL OVER THE BALL-TIP GUIDE WIRE INTO THE INTRAMEDULLARY CANAL OF THE PATIENT'S TIBIA. AS DOCTOR CONTINUED TO IMPACT THE STRIKE PLATE TO ADVANCE THE NAIL INTO ITS FINAL POSITION, THE DELTA STRIKE PLATE SHEARED OFF THE NAIL ADAPTER TIBIA SPI. THE THREADS OF THE DELTA STRIKE PLATE REMAINED ENGAGED IN THE NAIL ADAPTER TIBIA SPI, AND THE BREAKING POINT APPEARS TO BE AT THE JUNCTION OF THE STRIKE PLATE THREADS AND THE STRIKE PLATE SHAFT. ONCE THE STRIKE PLATE WAS BROKEN, THE SURGEON HELD THE BROKEN STRIKE PLATE IN ITS INTENDED POSITION AND FINISHED IMPACTING THE NAIL TO ITS FINAL POSITION. THEREAFTER, THE CASE CONTINUED AS NORMAL AND THERE WAS NO HARM DONE TO THE PATIENT AS A RESULT OF THE BREAKAGE. THERE WAS NOTHING UNUSUAL IN THE TECHNIQUE THE SURGEON USED TO IMPACT THE NAIL INCLUDING HOW HARD THEY WERE HITTING THE STRIKE PLATE. THE INSTRUMENTATION IN QUESTION IS NEW AND I WOULD ESTIMATE IT TO HAVE BEEN USED/ STERILIZED LESS THAN 30 TIMES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8867812 ↗
• MalfunctionAug 6, 2019Break; Fracture; Fracture

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INSERT THE PEN THROUGH THE STRIKE PLATE, BUT IT WAS BROKEN DURING HAMMERING. THE SMALL BROKEN PART WAS IN THE AIMING DEVICE AND WAS REMOVED BY THE MEDICAL TECHNOLOGY IN THE HOSPITAL. NO REPORTED METALLIC DEBRIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8867811 ↗
• MalfunctionJul 25, 2019Fracture; Break; Fracture; Detachment of Device or Device Component

  THE THREADS OF THE STRIKE PLATE 2351-0050 BROKE OFF INTO THE TARGETING ARM. NO SURGICAL DELAY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8827535 ↗
• MalfunctionJul 18, 2019Fracture; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON THE LEFT SIDE, UPON IMPACTION, THE THREADS OF THE STRIKE PLATE BROKE OFF IN THE TARGETER. A STRIKE PLATE FROM A GAMMA SET WAS OPENED AND USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH A DELAY OF LESS THAN 2 MINUTES. THE BROKEN-OFF THREADS WERE REMOVED FROM THE TARGETER POST-OP. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8805227 ↗
• MalfunctionJul 2, 2019Break

  IT WAS REPORTED THAT, WHILE UTILIZING T2 ALPHA TIBIA NAILING SYSTEM, THE STRIKE PLATE WAS TIGHTLY FASTENED TO THE SPI NAIL ADAPTER, AND AFTER THE STRIKE PLATE EXPERIENCED MULTIPLE HARD BLOWS FROM THE SLOTTED MALLET, THE STRIKE PLATE BROKE. USER BACKED THE NAIL OUT TO FIND THAT HARD CORTICAL BONE FROM THE FRACTURE HAD FALLEN INTO THE PATH OF THE NAIL, THUS MAKING IT HARD FOR THE NAIL TO SEAT TO ITS FINAL DESTINATION. PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8752670 ↗
• MalfunctionJun 25, 2019Fracture; Crack; Fracture

  DOCTOR INFORMED SALES REP THAT THE INSTRUMENT CRACKED ABOVE THE THREADS WHEN PUNCHING THE NAIL OUTWARDS. CUSTOMER USED ANOTHER INSTRUMENT. SURGICAL DELAY OF ABOUT 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8732804 ↗
• MalfunctionJun 20, 2019Fracture; Break; Fracture

  OUR PRODUCT MANAGER REPORTED: "DURING A SURGERY AT (B)(6) WITH THE NEW T2 ALPHA TIBIA NAIL, THERE WAS AN ISSUE WITH THE CONNECTION OF THE DELTA STRIKE PLATE WITH THE NAIL ADAPTER TIBIA SPI AND WE HAVE BELOW THE SPECIFIC COMMENT FROM [SURGEON] ADDED IN THE EPS FORM: THREAD OF THE DELTA STRIKE PLATE IS TOO SHORT: BROKE WITH SLIGHT HAMMER BLOWS" NO ISSUE WITH THE SURGERY IN TERMS OF TIMING AND FINAL RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8716088 ↗
• MalfunctionJun 18, 2019Fracture; Break; Fracture; Device Fell

  IT WAS REPORTED THAT WHILE MALLETING IN A GT-T2 ALPHA NAIL, THE STRIKE PLATE BROKE AT THE THREADS, OFF THE TARGETER AND FELL TO THE FLOOR. THE THREADS OF THE STRIKE PLATE WERE STUCK IN THE THREADED HOLE OF THE TARGETER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8709491 ↗
• MalfunctionJun 4, 2019Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A LEFT FEMUR, THE THREADS OF THE STRIKE PLATE BROKE OFF IN THE TARGETED UPON IMPACTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8668143 ↗
• MalfunctionJun 4, 2019Fracture; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT FEMUR, UPON BACK-SLAPPING THE NAIL, THE THREADS OF THE STRIKE PLATE BROKE OFF INTO THE JIG. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8667942 ↗