MAUDE Adverse Event Report: OSTEOMED, LLC 2.0MM X 6MM AUTO-DRIVE SCREW; SCREW, FIXATION, BONE

Model Number	211-2006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the screw broke during surgery.The device was not received for evaluation.The event occurred in 2019; however, osteomed did not become aware of this event until (b)(6) 2023.No additional units of the part number/lot number in question remained in inventory for review.A two-year review of the complaint database for the part number 211-20xx part family was performed and revealed two (2) complaints for the issue of "screw broke" ( one of which is the complaint in this report).As stated in the risk documentation and instructions for use (ifu), potential root causes of the reported event could be improper design, very dense bone, not inserting using a taperlock screwdriver, not inserting the screw into the bone at a 90° angle, and not pilot drilling for high density bone, wrong/undersized pilot hole, wrong screw size/length chosen for the application.However, as the device was not received for evaluation, based on the information received, the root cause could not be determined.
Event or Problem Description
An "adverse event report" was received from the health authority in china.Per the adverse event report, "the patient was diagnosed with an "aneurysm" and underwent aneurysm clipping surgery under general anesthesia on (b)(6) 2019.When using the craniofacial plate fixation system for skull repair, the screw breakage occurred.The screw was immediately removed and replaced with a new one without any abnormalities".It was also reported "no adverse effects on the patient".The event was reported to have occurred in (b)(6) 2019 but had not been reported to osteomed, the screws involved in the incident were not provided for our investigation.No adverse patient consequences were reported.

• Brand Name: 2.0MM X 6MM AUTO-DRIVE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• 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: 17808111
• Report Number: 2027754-2023-00030
• Device Sequence Number: 6954138
• Product Code: HWC
• UDI-Device Identifier: 00845694002448
• UDI-Public: (01)00845694002448(10)1130208(30)1(11)180920
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2023

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
• Operator of Device: Health Professional
• Device Model Number: 211-2006
• Device Catalogue Number: 211-2006
• Device Lot Number: 1130208
• 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: 09/14/2023
• Initial Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 44 YR
• Patient Sex: Female