IMHS 71687012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010519207), received between Jun 8, 2020 and Jun 8, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K122170); 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT IN (B)(6) 2015 PATIENT UNDERWENT A STRYKER THR PROCEDURE, DUE TO RECURRENT EFFUSIONS WITHOUT ANY RESOLUTIONS, DESPITE ASPIRATIONS AND INJECTIONS A REVISION SURGERY HAD TO BE PERFORMED IN (B)(6) 2016. DURING THAT PROCEDURE, DR. DECIDED TO USE AN UNDERSIZED FEMORAL TRIAL WHICH WAS INSERTED INTO THE KNEE. THE TRIAL ITSELF CONTAINED A CLEAR DIRECTIVE PRINTED ON ITSELF TO NO INSERT INTO THE BODY. THE TRIAL HAD BEEN FORCIBLY PUSHED IN THE FEMUR, REQUIRING LYTES AND SUCTION TO REMOVE IT. DEVICE DID NOT HAVE A PROPER LOCKING MECHANISMS, INSTEAD USING A POP-ON, POP-OFF MECHANISM ON THE TRIAL THAT RESULTED IN A PIECE OF TRIAL BEING LEFT BEHIND. BECAUSE OF THIS INCIDENT, PATIENT CONTINUED TO HAVE PAIN AND SWELLING. A THIRD PROCEDURE HAD TO BE PERFORMED IN ORDER TO TAKE THE PIECE OUT OF THE TRIAL OF THE PATIENTS BODY.

  Patient problems: Injury

  MAUDE report 10126862 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122170. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2020 · Oct 7, 2019 · Terminated
  LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted sha