NA 03.045.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 10886982292513), received between Sep 13, 2021 and Sep 21, 2026 — classified as 3 injuries, 155 malfunctions.

The most frequently reported specific device problem is “Break” (141 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 25 most recent of 158 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Use of Device Problem

  It was reported that the tip of the retention pin was found missing during tray setup. There was no surgical delay. It was noted during manufacturers investigation that the tip was broken off.

  Patient problems: Insufficient Information

  MAUDE report 50841297 ↗
• MalfunctionAug 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50498467 ↗
• MalfunctionAug 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379982 ↗
• MalfunctionAug 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379958 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RETENTION PIN BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094905 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE THREADED PORTION OF THE RETENTION PIN WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24861095 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT THE RETENTION PIN SHORT XL25 EXPERIENCED A FAILURE DURING INTRA-OPERATIVE USE. THE EVENT INVOLVED THE THREAD OF THE RETAINING SCREW COMING OFF OR BREAKING WHILE INSERTING A BOLT WITH A SCREWDRIVER. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830960 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT DURING NAILING, WHEN THE LOCKING SCREW (FOR MEDULLARY NAILING) WAS SCREWED INTO TO THE BONE FROM THE RETENTION PIN INSTRUMENT, THE THREADED PART OF THE RETENTION PIN BROKE OFF AND REMAINED INSIDE THE SCREW HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791820 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE RETENTION PIN HAS SNAPPED OFF. IT IS BELIEVED IT HAPPENED DURING A NAILING CASE, BUT ONLY REALIZED THE ITEM WAS BROKEN WHEN IT WAS TO BE USED FOR A DIFFERENT CASE. THERE WAS NO PATIENT HARM REPORTED AND NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757840 ↗
• MalfunctionMar 17, 2026Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE EVENT HAPPENED INTRA-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620053 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT RETENTION PIN IS BROKEN. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507099 ↗
• MalfunctionMar 2, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT THE RETENTION PIN HEAD BROKE OFF AND WAS RETAINED INSIDE IMPLANTED SCREW.

  Patient problems: Foreign Body In Patient

  MAUDE report 24485163 ↗
• MalfunctionFeb 27, 2026Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE TIP OF SCREWDRIVER INSERTER WAS FOUND TO BE BROKEN DURING TRAY SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470498 ↗
• MalfunctionJan 30, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY WITH TNA FOR TIBIAL SHAFT FRACTURES. DURING INSERTION OF A LOW-PROFILE SCREW INTO THE FOURTH ML HOLE FROM THE DISTAL END, THE RETENTION PIN BROKE OFF WHEN THE SCREW HEAD WAS PARTIALLY EMBEDDED. THE BROKEN TIP REMAINED IN THE SCREW HEAD, BUT THE SURGEON CLOSED THE WOUND AS IS BECAUSE THERE WAS NO PROBLEM WITH FIXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES OF DELAY.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 24224551 ↗
• MalfunctionDec 24, 2025Break; Break

  DURING AN RFNA PROCEDURE, THREE INSTRUMENTS FAILED WHILE IN USE. THEY WERE NOT MISUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888508 ↗
• MalfunctionDec 22, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF WITH THE RETENTION PIN. WHEN THE SURGEON TRIED TO INSERT THE PROXIMAL SCREW FOR RFNA, THE SCREW WAS DIFFICULT TO INSERT AND THE TIP OF THE RETENTION PIN BROKE OFF, BECOMING LODGED IN THE SCREW HEAD AND UNABLE TO BE REMOVED. IT WAS NOTED THE PATIENT'S BONE QUALITY WAS GOOD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23867084 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THAT ON NOVEMBER 25, THE PATIENT UNDERWENT ORIF SURGERY FOR TIBIAL SHAFT FRACTURES ON THE RIGHT SIDE. THE PRODUCT IN QUESTION WAS USED FOR HOLDING SCREWS, AND IT BROKE OFF AT THE THREADED PART DURING A SCREW INSERTION. BECAUSE A BROKEN PIECE OF THE PRODUCT REMAINED STUCK IN THE SCREW HEAD, THE SCREW WAS REMOVED. NO RESIDUE IS LEFT IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802382 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THE RETENTION PIN WAS BROKEN ON AN UNKNOWN DATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769301 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY FOR SUPRACONDYLAR FRACTURES OF THE FEMUR WITH RFNA. DURING PROXIMAL LOCKING, THE SCREW BECAME STUCK AND THE THREADED TIP OF THE RETENTION PIN BROKE OFF AND REMAINED INSIDE THE SCREW HEAD. THE SCREW WAS REMOVED, AND A NEW ONE WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES OF DELAY. ACCORDING TO THE SURGEON, BECAUSE THE DRILLING WAS PERFORMED SLIGHTLY OBLIQUE TO THE NAIL HOLE, THE BREAK-OFF CAUSED BY METAL FATIGUE OCCURRED WHILE INSERTING THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743758 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT THE RETENTION PIN WAS BROKEN OFF WHILE TRYING TO REMOVE FROM SCREWDRIVER IN CSPD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697074 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT THE RETENTION PIN WAS BROKEN OFF WHILE TRYING TO REMOVE FROM SCREWDRIVER IN CSPD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695019 ↗
• MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT INTRA-OPERATIVELY THERE WERE BROKEN INSTRUMENTS: - RETENTION PIN WAS STRIPPED WHEN INSERTING SCREWS WITH XL25 SCREWDRIVER FOR DISTAL LOCKING. - DRIVING CAP WAS MOUNTED ONTO INSERTION HANDLE, AFTER FEW LIGHTS BLOWS WITH SURGICAL MALLET, THE DRIVING CAP LOOSENED FROM THE INSERTION HANDLE. IT APPEARS THE END OF THE DRIVING CAP HAS STRIPPED OF SLIGHTLY AND STILL INSIDE THE INSERTION HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556539 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INTERTROCH FRACTURE. SURGEON CHOSE TO FIX WITH TFNA. WHILE INSERTING DISTAL SCREW, THE RETENTION PIN THREADS BROKE OFF INTO THE HEAD OF THE SCREW. SURGEON REMOVED SCREW AND FRAGMENT SUCCESSFULLY. ADDITIONAL X-RAY TAKEN TO CONFIRM ALL PIECES REMOVED. A NEW SCREW WAS INSERTED. CASE COMPLETED SUCCESSFULLY WITH FIVE (5) MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478633 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THAT THREADS OF RETENTION PIN WERE BROKEN OFF. TIP OF RETENTION PIN (WHERE THREADS ARE AT THE TIP) ARE BROKEN OFF. ALL PIECES WERE NOT RETRIEVED. THE ISSUE WAS DISCOVERED POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457968 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THAT THREADS OF RETENTION PIN WERE BROKEN OFF. TIP OF RETENTION PIN (WHERE THREADS ARE AT THE TIP) ARE BROKEN OFF. ALL PIECES WERE NOT RETRIEVED. THE ISSUE WAS DISCOVERED POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457381 ↗