INTERTAN 71934479Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556105092), received between May 10, 2017 and Nov 15, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (7 reports).

10 other recalls cover devices cleared under the same FDA submission (K040212, K210980); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PERFORMED ON (B)(6)2023, THE PATIENT FELL AT HOME, THUS DETERMINING THE REMOVAL OF THE INTERTAN 10MM X 24CM 125D AND TRIGEN LOW PROFILE SCREW 5.0MM X 30MM IN A REVISION SURGERY PERFORMED ON (B)(6)2024. THE LAG SCREW WAS REMOVED PREVIOUSLY (LOGGED ON (B)(4)) PRIOR TO THE PATIENT FALLING. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fall

  MAUDE report 20700823 ↗
• InjuryMar 18, 2024Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED PROXIMAL PORTION BREAKAGE OF THE NAIL. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE ENTIRE NAIL WAS REMOVED. SURGEON THEN WENT TO REMOVE THE COMPRESSION SCREW, WHICH THEN REALIZED THE TIP WAS BROKEN OFF. HE WAS ABLE TO REMOVE THE COMPRESSION SCREW BY SLIDING AN OSTEOTOME INFERIOR TO THE COMPRESSION SCREW TO CREATE SOME SPACE, AND THEN HE SLID THAT SAME OSTEOTOME IN BETWEEN THE LAG AND COMPRESSION SCREW TO SEPARATE THEM. HE REMOVED THE LAG SCREW AND PULLED THE REMAINING COMPRESSION SCREW OUT WITH A BULLDOG. HE THEN USED A STRYKER NAIL EXTRACTOR TO GET THE REST OF THE NAIL OUT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18927060 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S RIGHT FEMUR ON (B)(6) 2017 TO TREAT AN INTERTROCHANTERIC FRACTURE, THE PATIENT EXPERIENCED PAIN IN THE LATERAL PORTION OF THE RIGHT HIP AND TROCHANTERIC BURSITIS. IN OR AROUND (B)(6) 2019, THE PATIENT RECEIVED A STEROID INJECTION TO RELIEF THESE SYMPTOMS. ADDITIONAL DETAILS REGARDING THE CLINICAL COURSE OF THE PATIENT WERE NOT PROVIDED. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Inflammation; Pain

  MAUDE report 15749629 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S LEFT FEMUR ON (B)(6) 2016 TO TREAT A COMMINUTED INTERTROCHANTERIC FRACTURE, THE PATIENT EXPERIENCED LATERAL INTERMITTENT HIP PAIN AND TROCHANTERIC BURSITIS FORTY THREE (43) WEEKS POSTOPERATIVELY. THE PATIENT WAS TREATED WITH A CORTICOSTEROID INJECTION IN OR AROUND (B)(6) 2017 TO RELIEF THE SYMPTOMS. ADDITIONAL DETAILS REGARDING THE CLINICAL COURSE OF THE PATIENT WERE NOT PROVIDED. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Discomfort; Inflammation

  MAUDE report 15480417 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S LEFT FEMUR ON (B)(6) 2017 TO TREAT AN INTERTROCHANTERIC FRACTURE, THE PATIENT EXPERIENCED A SIGNIFICANT AMOUNT OF LATERAL HIP PAIN, A PROXIMAL SCREW BACKING OUT AND DEVELOPED A LIMB LENGTH DISCREPANCY DUE TO HEALED FRACTURE REDUCTION 59.7 WEEKS POSTOPERATIVELY. THE PATIENT UNDERWENT THE PROXIMAL SCREW REMOVAL ON (B)(6) 2018 AND HARDWARE EXCHANGE TO A TOTAL HIP ARTHROPLASTY ON (B)(6) 2018. ADDITIONAL DETAILS REGARDING THE CLINICAL COURSE OF THE PATIENT WERE NOT PROVIDED. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Discomfort; Failure of Implant; Unequal Limb Length

  MAUDE report 15474964 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A TRAUMA REVISION SURGERY WHERE A LAG/COMP SCREW KIT WAS EXCHANGED DUE TO EARLY PAINFUL CUTOUT, SLIGHT PENETRATION INTO THE ACETABULUM AND A SUSTAINED FEMORAL NECK FRACTURE ON (B)(6) 2021 ((B)(4)), THE PATIENT EXPERIENCED A STABLE COLLAPSE OF THE SUPERIOR ASPECT OF THE FEMORAL HEAD WITH SCREW INTRUSION INTO THE HIP JOINT AS STATED WITHIN NOTES RELATED TO AN OFFICE VISIT CONDUCTED IN OR AROUND (B)(6) 2022 WHERE POSTOPERATIVE X-RAYS WERE ANALYZED. THE SURGEON RECOMMENDED EITHER A HARDWARE REMOVAL OR A CONVERSION TO A TOTAL HIP REPLACEMENT SYSTEM AS OPTIONS TO TREAT THESE COMPLICATIONS, BUT THE PATIENT WAS NOT INTERESTED IN THESE OPTIONS. FURTHER DETAILS REGARDING THE PATIENT'S FINAL OUTCOME ARE NOT KNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Perforation

  MAUDE report 15459779 ↗
• InjurySep 24, 2021Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WAS PERFORMED ON AN UNSPECIFIED DATE, AN INTERTAN 10MM X 24CM 125D BROKE OFF. ON (B)(6) 2021 THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE BROKEN NAIL AND A SYNTHES COMPRESSION PLATE WAS IMPLANTED INSTEAD. PATIENT OUTCOME REMAINS UNKNOWN. CLINICAL INFORMATION NOT AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 12526502 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT, AN INTERTAN 10MM X 24CM 125D WAS BROKEN. IT IS UNKNOWN IF THIS HAPPENED DURING SURGERY OR NOT, THEREFORE PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12498060 ↗
• InjuryAug 13, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A PRIMARY SURGERY, ONE INTERTAN 10MM X 24CM 125D BROKE. AFTER THAT, A REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN NAIL AND REPLACE IT. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12319250 ↗
• InjuryMar 14, 2021Break; Break

  IT WAS REPORTED THAT, AN INTERTAN 10MM X 24CM 125D BROKE INSIDE THE PATIENT, PROXIMALLY JUST ABOVE THE LAG SCREW. A REVISION SURGERY WAS PERFORMED AND THE DEVICE WAS REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11478934 ↗
• InjuryNov 4, 2020Break; Break

  IT WAS REPORTED THAT A BROKEN NAIL WAS REMOVED FROM THE PATIENT. INJURY REPORTED. NO FURTHER INFORMATION AVAILABLE. IT IS UNKNOWN WHEN THIS HAPPENED.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10785742 ↗
• InjuryMay 10, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT THE INTERTAN BROKE FOUR AND A HALF MONTHS OUT.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6556342 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040212, K210980. One submission often covers many models, so check the product and lot details in each record.

• Z-2456-2026 · Mar 16, 2026 · Open, Classified
  TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• Z-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• Z-1133-2022 · Apr 22, 2022 · Open, Classified
  INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
• Z-0772-2021 · Nov 2, 2020 · Terminated
  Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long
• Z-0097-2018 · Oct 24, 2017 · Open, Classified
  smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
• Z-2258-2014 · Jul 2, 2014 · Terminated
  TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71
• Z-1636-2014 · Apr 4, 2014 · Terminated
  TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204,
• Z-1637-2014 · Apr 4, 2014 · Terminated
  TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree