MAUDE Adverse Event Report: OSTEOMED, LLC 2.0MM MMF X 11MM AUTO-DRIVE SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number	209-2011-SP-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Screw breaking during insertion was reported.The device was not returned for evaluation.Review of the device history record revealed no anomalies.A review of the complaint database was performed.A review for the part number 209-20xx part family revealed seven (7) complaints for this part family (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.
Event or Problem Description
It was reported the part number 209-2011-sp-01 screw broke during insertion in the patient's mandible during surgery.The surgeon was able to extract and recover the broken portion of the screw from the patient.This issue prolonged the surgery by 30 minutes.No other adverse patient consequences were reported.

• Brand Name: 2.0MM MMF X 11MM AUTO-DRIVE SCREW
• Common Device Name: 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: 19268345
• Report Number: 2027754-2024-00027
• Device Sequence Number: 6949301
• Product Code: DZL
• UDI-Device Identifier: 00845694001052
• UDI-Public: (01)00845694001052(10)1164533(30)1(11)220222
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: 209-2011-SP-01
• Device Catalogue Number: 209-2011-SP-01
• Device Lot Number: 1164533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown