MAUDE Adverse Event Report: OSTEOMED, LLC 2.0MM X 8MM MMF AUTO-DRIVE SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number 209-2008

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

It was reported the screw head broke off when explanting the imf screw from the patient's mandible.The shaft of the screw was left in the patient.Attempts to obtain further information and the remaining portion of the screw were made to no avail.Review of the dhr could not take place as device lot number was unknown.A review of the complaint database for the 209-20xx part family revealed one (1) complaint for screw head breakage during explant, which is the complaint within this report.Potential causes for screw breakage include but are not limited to inadequate design, inadequate specifications for intended use, improper material selection, and wrong screw length/size selected for intended application; however, based on the information received and the investigation performed, the root cause could not be determined.

Event Description

It was reported when explanting the 2.0 x 8mm imf screw from the patient's mandible, the head of the screw broke off.The shaft of the screw was left in the patient.This issue prolonged the surgery by 2 minutes.Details around why the explant was being performed are unknown despite follow up attempts.

• Brand Name: 2.0MM X 8MM MMF AUTO-DRIVE SCREW
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 18682520
• MDR Text Key: 335247248
• Report Number: 2027754-2024-00022
• Device Sequence Number: 1
• Product Code: DZL
• 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: Physician
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209-2008
• Device Catalogue Number: 209-2008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 26 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White