MAUDE Adverse Event Report: EXSOMED CORPORATION INNATE INSTRUMENT KIT FOR 4.5MM; PASSER, WIRE, ORTHOPEDIC

Model Number EXINN914500

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2023

Event Type  malfunction  

Event Description

User facility medwatch report # (b)(4) was received on 8/21/2023.It was reported "last case of doctor in operating room a guide wire broke while drilling leaving a portion inside the patients hand (metacarpal).The portion was retrieved, aligned, and compared to similar guide wire.Wire matched the length.Portable x-ray was ordered for verification.X-ray was taken before suturing the surgical site.Image was sent to radiologist for reading and analysis.Doctors spoke over the phone and verified that there was no retained foreign body.Surgical site was completely closed and patient was transferred to pacu".There were no adverse patient consequences reported.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not received for evaluation.Manufacturing and inspection records could not be reviewed as device batch/lot number is unknown.Based on the information received, the root cause could not be determined.

• Brand Name: INNATE INSTRUMENT KIT FOR 4.5MM
• 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: 17746149
• MDR Text Key: 323415765
• Report Number: 3012835528-2023-00003
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EXINN914500
• Device Catalogue Number: EXINN914500
• Device Lot Number: 22304-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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
• Patient Age: 41 YR
• Patient Sex: Female