NA 321.12Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982190369), received between Jan 9, 2017 and Sep 15, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Crack; Material Twisted/Bent; Illegible Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780287 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT IN (B)(6) 2024, A PROPHYLACTIC TFNA WAS INSERTED TO THE PATIENT¿S LEFT HIP ALONG WITH A CEMENT SPACER WHERE THERE WAS A CANCER TUMOR NEAR THE INTERTROCHANTERIC REGION. MONTHS LATER AS EXPECTED, A FRACTURE OCCURRED AND CONTINUED TO A NON-UNION. ON (B)(6) 2025, THE TFNA WAS REMOVED INCLUDING THE LAG SCREW, THE NAIL AND BOTH INTERLOCKING DISTAL SCREWS. THE 5.0 DISTAL INTERLOCKING SCREWS WERE BROKEN, AND BOTH WERE RETRIEVED, EXCEPT ONE PIECE OF THE MOST DISTAL SCREW. THE SURGEON WAS NOT CONCERNED AND LEFT IT IN THE FEMUR. THE REVISION THEN CONTINUED BY REMOVING THE CEMENT SPACER FOLLOWED BY USING THE REAMER IRRIGATOR ASPIRATOR TO COLLECT BONE GRAFT. THEN A 95° BLADE PLATE 80 MM BLADE WAS INSERTED, WHILE REDUCING WITH THE ARTICULATING TENSION DEVICE ITEM NUMBER 321.12 THE SMALL PINS SHEARED, AND THE ARTICULATING TENSION DEVICE BROKE. ALL PARTS WERE REMOVED WITH EASE. THEN A NEW ARTICULATING TENSION DEVICE WAS INTRODUCED. THE REST OF THE CASE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAYS AND NO PATIENT HARM. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVI

  Patient problems: Insufficient Information

  MAUDE report 21439040 ↗
• MalfunctionJul 18, 2022Break; Break

  IT WAS REPORTED ON UNKNOWN DATE THAT, THE PATIENT HAD AN EXISTING 4.5MM LCP PROXIMAL TIBIA PLATE. THE INTENT WAS TO TENSION THE LATERAL SIDE TO REDUCE THE MALUNION/NON UNION THEN NAIL THE TIBIA AND AUGMENT THE MEDIAL SIDE WITH A BUTTRESS PLATE. UPON PLACEMENT OF THE ATD ON THE EXISTING LATER PLATE, THE HOOK FROM THE ATD SWIVEL BROKE OFF. WE RETRIEVED THE ITEM FROM THE PATIENT, NO RESIDUAL FRAGMENTS WERE LEFT IN THE PATIENTS. WE USED A NEW ATD AND IT WORKED FINE. WHEN NAILING THE TIBIA THE POLY INSIDE THE TNA NAIL BECAME DAMAGED WHEN TRYING TO REMOVE THE GOLD "TEAR DROP" ZIMMER GUIDE ROD (47-2490-097-00) AFTER INSERTION OF THE NAIL. WE REALIZED IT WHEN WE WERE ROTATING THE TNA SUPRAPATELLAR HANDLE ATTACHED TO THE NAIL BUT THE HOLES IN THE NAIL ON X RAY WERE NOT MOVING. SO WE REMOVED THE NAIL AND HAD TO REAM UP AND USE THE NEXT SIZE DIAMETER NAIL. WE ONLY HAD ONE EACH OF THE TNA SIZES. THERE WERE A SURGICAL DELAY OF 20 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR AN ARTICULATED TENSION DEVICE WITH GAUGE-SPAN 20MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15042729 ↗
• MalfunctionJul 5, 2021Break; Break

  IT WAS FURTHER REPORTED THAT THE PROXIMAL END OF THE NAIL SEEMED TO BE BENT AT THE CONNECTING PART OF THE NAIL, DUE TO TRYING TO ROTATE THE NAIL INSIDE THE CANAL WHILE ATTACHED TO THE INSERTION HANDLE. THIS REPORT (B)(4) CAPTURES THE INTRA-OPERATIVE EVENT WHERE THE HOOK FROM THE ATD SWIVEL BROKE OFF AND TIBIAL NAIL BECAME DAMAGED WHILE RELATED COMPLAINT (B)(4) CAPTURES THE POST-OPERATIVE EVENT WHERE THE PATIENT HAD AN EXISTING 4.5MM LCP PROXIMAL TIBIA PLATE. THE INTENT WAS TO TENSION THE LATERAL SIDE TO REDUCE THE MALUNION/NON-UNION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119135 ↗
• MalfunctionFeb 5, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION, WHILE RESTOCKING THE SET, THE SCREW INSIDE TENS-DEV-ARCTIC SPAN IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT PRODUCT REPORTED: ARTICULATED TENSION DEVICE WITH GAUGE-SPAN 20MM (PART #321.12-US, LOT#1058, QTY. UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ARTICULATED TENSION DEVICE WITH GAUGE-SPAN 20MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11285332 ↗
• MalfunctionMay 5, 2020Break; Break

  UPDATED EVENT: THE ARTICULATED TENSION DEVICE MALFUNCTIONED AND BROKE WHILE BEING USED IN A CASE. IMMEDIATELY OPENED ANOTHER TRAY TO USE A SECOND DEVICE THAT WORKED PROPERLY. A TINY WASHER CAME OFF OF THE TENSIONING DEVICE AND WAS DROPPED ON THE FLOOR AND NOT RECOVERED AT THE END OF SURGERY. FRAGMENTS WERE GENERATED BUT WERE REMOVED EASILY. THERE WAS A DELAY IN SURGERY FOR ABOUT ONE (1) MINUTE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10026960 ↗
• MalfunctionJan 9, 2017Break; Break

  IT WAS REPORTED THAT AN ARTICULATED TENSION DEVICE WITH GAUGE-SPAN 20MM (ATD) BROKE OFF DURING AN INITIAL ROTATIONAL OSTEOTOMY SURGERY ON (B)(6) 2016. THE SURGEON WAS TENSIONING WITH THE ATD WHEN HE HEARD A SNAP, HE NOTICED THAT THE TOOTH HAD BROKEN OFF WHERE IT HOLDS ONTO THE PLATE (95 DEGREE CONDYLAR PLATE 5 HOLES/60MM/92MM). THE PIECE WAS RETRIEVED. ANOTHER ATD WAS AVAILABLE AND THE SURGEON WENT ON AS PLANNED WITH THE CASE. THE PLATE WAS NOT AFFECTED IN ANY WAY AND REMAINS IMPLANTED IN THE PATIENT. THERE WAS NO MEDICAL INTERVENTION, SURGICAL DELAY OR PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: 95 DEGREE CONDYLAR PLATE 5 HOLES/60MM/92MM (PART #237.52, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) ARTICULATE TENSION DEVICE WITH GAUGE-SPAN 20MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233743 ↗