MAUDE Adverse Event Report: EXSOMED CORPORATION INFRAME IMPLANT 2.0MM X 34MM; PASSER, WIRE, ORTHOPEDIC

Model Number EXINF922034

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

It was reported during surgery, "the surgeon used the inframe for a fix.After measuring, the surgeon advanced the guide wire.The guide wire broke at the transition point between thick and thin end.The surgeon tried to put the thicker end at the distal portion of the phalanx and try to put the smaller end of the guide wire up the phalanx to try to match the trajectory.When inserting the nail, after final tightening, the nail broke in the phalanx."dr.Wilkerson believes this was just because the guide wire broke initially." it was also reported the "surgeon removed the broken head of inframe and tried to remove the broken shaft.It was also reported the surgeon tried to use trephines to remove, also tried to use a needle driver to unthread.The surgeon was unsuccessful in removing the shaft.The surgeon pinned the phalanx, left the broken nail in the phalanx.The surgeon ended up using a hospital owned k-wire to provide additional fixation." the surgery was completed after a 30-minute delay.There were no adverse patient consequences reported.This report is related to report number 3012835528-2023-00006 for the device involved in this event.

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found.The results of the investigation are inconclusive as the device was not received for evaluation.Based on the information received, the root cause could not be determined.

• Brand Name: INFRAME IMPLANT 2.0MM X 34MM
• Type of Device: PASSER, WIRE, ORTHOPEDIC
• Manufacturer (Section D): EXSOMED CORPORATION; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): EXSOMED CORPORATION; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 18065507
• MDR Text Key: 327287009
• Report Number: 3012835528-2023-00005
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EXINF922034
• Device Catalogue Number: EXINF922034
• Device Lot Number: 22125-13
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1