MAUDE Adverse Event Report: MEDARTIS INC. STEALTHFIX INTRAOSSEOUS FIXATION SYSTEM; OLIVE WIRE

Catalog Number SAOLIVELGS

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2023

Event Type  Injury  

Event Description

While using a threaded olive wire to hold down the most proximal hole in the anterior plate, the olive wire broke off just below the olive, and could not be retrieved.The threaded portion of the olive wire was left inside the patient, and a screw was put in off axis to the hole to make sure they have fixation.There was a short delay but the surgeon was very pleased with the case.

Manufacturer Narrative

If any information is provided that changes the outcome of the investigation, a follow up report will be filed.

• Brand Name: STEALTHFIX INTRAOSSEOUS FIXATION SYSTEM
• Type of Device: OLIVE WIRE
• Manufacturer (Section D): MEDARTIS INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer (Section G): MEDARTIS INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer Contact: travis christman ; 1195 polk drive; warsaw, IN 46582 ; 5744531654
• MDR Report Key: 17828334
• MDR Text Key: 324402214
• Report Number: 3009540749-2023-00006
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: SAOLIVELGS
• Device Lot Number: 2361336293
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1