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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

It was reported the screw broke during insertion in the patient's mandible.It was also reported the surgeon "dug around" to recover the end of the screw in the patient's bone.This prolonged the surgery by 30 minutes.No other adverse patient consequences were reported.

Manufacturer Narrative

It was reported the device is available for evaluation.Product return is currently pending.A follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Screw breaking during insertion was reported.The device has not been returned for evaluation.Review of the dhr and inventory review could not be performed as device lot number is unknown.A two-year review of the complaint database was performed.A review for the part number 209-20xx part family revealed five (5) complaints for screws breaking during insertion (one of which is the complaint in this report).Potential causes for screws breaking during insertion include improper design, wrong size/length chosen for intended application, inadequate specifications for intended use, excessive torque used during insertion, high density bone, and improper material selection.However, based on the information received and the investigation performed, the root cause could not be determined.Corrected data: type of investigation (annex b) updated to: 4114 and 4109 investigation findings (annex c) updated to: 3221 investigation conclusions (annex d) updated to: 4315.

• 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: 18308235
• MDR Text Key: 330226151
• Report Number: 2027754-2023-00072
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 12/21/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male