NA 03.033.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982271112), received between Oct 29, 2020 and Sep 30, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Device-Device Incompatibility

  It was reported that the coupling of protection sleeve is broken and won't lock into his handle. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945534 ↗
• MalfunctionNov 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TROCAR AND HANDLE ARE BLOCKED IT WAS NOT POSSIBLE TO REMOVE THE TWO FROM EACH OTHER. THE ISSUE WAS IDENTIFIED PRE-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510349 ↗
• MalfunctionAug 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SLEEVES DO NO FIT IN HANDLES AND GET STUCK. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737243 ↗
• MalfunctionNov 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON NOVEMBER 4, 2024, DURING A TRAINING SESSION, THE ITEM GOT BLOCKED WITHOUT HAVING BEING USED. THERE WAS NO REASON FOR IT TO BLOCK/GET DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696047 ↗
• MalfunctionOct 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE WITH THE SURGEON, THERE WAS A MIDSHAFT FEMUR FRACTURE. DURING INSERTION OF THE NAIL, THE RECON SCREW MISSED THE NAIL AND THE DRILL BIT FOR THE STATIC 5.0 SCREW HIT THE NAIL ANTERIOR. THE SURGEON WANTED ALL INSERTION HANDLES, AIMING ARMS AND CONNECTING SCREWS REPLACED. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20526901 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 14MM PROTECTION SLEEVE. THIS IS REPORT 4 OF 8 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED IN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19694224 ↗
• MalfunctionSep 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE TISSUE PROTECTOR IS STUCK AND BROKEN IN THE HANDLE POSTOPERATIVELY. IT WAS UNKNOWN WHAT TYPE OF POSTOPERATIVE PROCEDURE PERFORMED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) 14MM PROTECTION SLEEVE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533461 ↗
• MalfunctionMay 25, 2021Device-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 WHILE EDUCATING THE NURSING STAFF ON THE FEMORAL RECON NAIL INSTRUMENTS, THE SILICON HANDLE WITH QUICK COUPLING AND PROTECTION SLEEVE WOULD NOT CONNECT PROPERLY. THEY ENDED UP PARTIALLY CONNECTED AND COULD NOT BE PULL THEM APART. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 14MM PROTECTION SLEEVE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11880959 ↗
• MalfunctionOct 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, A COUPLE OF PIECES OF SET STUCK TOGETHER, ITS DEFECTIVE. THE SALES CONSULTANT JUST RECEIVED THE NEW SET AND WAS PUTTING IT TOGETHER WHEN HE NOTICED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 14MM PROTECTION SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10756136 ↗