MAUDE Adverse Event Report: OSTEOMED, LLC 1.6MM X 4MM SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number 208-1604

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2023

Event Type  malfunction  

Event Description

It was initially reported during a craniotomy procedure, the part number 208-1604 screw went through the diameter of the screw hole on the profile zero plate.The screw was removed and another 208-1604 screw was used to complete the procedure.There were no adverse patient consequences, and the procedure was not prolonged.The lot number of the reported screw is unknown.The complaint screw was not returned for evaluation; however, other screws were returned.These screws were evaluated on 05 may 2023, and based on the findings of the device evaluation, this report is being submitted.

Manufacturer Narrative

The reported event of the profile zero screw not locking into the plate and going through the diameter of the screw hole was received.The screw used during the case that was reported to have gone through the plate was not retained to be returned for evaluation.However, other screws in the set were visually inspected by the field representative and returned for further evaluation.These returned screws were inspection by the quality control team on 05 may 2023 and were confirmed to have a screw head that did not meet specification and were undersized.Evaluation from the quality control and manufacturing team found a broken cut off tool in the manufacturing process was the most likely cause of the nonconformance.A follow up report will be submitted.

Manufacturer Narrative

Further investigation was performed via a health hazard evaluation (hhe) which revealed the root cause of the undersized screw head was that during machining, the cut off tool broke, resulting in undersized screw head diameters.As a result of the hhe, a field action is being initiated and has been reported to the recall coordinators via 806 package.

• Brand Name: 1.6MM X 4MM 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: 16913972
• MDR Text Key: 315309641
• Report Number: 2027754-2023-00015
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 208-1604
• Device Catalogue Number: 208-1604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2027754-05/25/2023-001-R
• Patient Sequence Number: 1