MAUDE Adverse Event Report: OSTEOMED, LLC ASSEMBLY, BLOCK, 3.0/4.0MM CANNULATED HEADLESS; SCREW, FIXATION, BONE

Model Number 316-1350

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.

Event Description

It was reported during the procedure on (b)(6) 2022, the doctor tried to take the screw from the tray, but the screw (extremifix 4.0mm screws) went through the screw tray (part number 316-1350).It was difficult to remove the screw when the base of the screw was below the tray.It was reported the screw would also break when trying to remove it from the tray.Because of the tray, several 4.0mm screws were damaged.The tray/devices ended up not being used as a result, and a system from another manufacturer was used to complete the procedure.It was reported this issue prolonged the procedure by 10 minutes since another tray needed to be brought into the operating room.There were no adverse patient consequences.

Manufacturer Narrative

The device was not returned for evaluation as follow up determined the device was not available for return.However, an image was provided by the complainant.Based on review of the aforementioned image, the reported event was confirmed as the image showed a screw stuck in the tray.A two-year review of complaints for this device revealed no other complaints for this issue.As the device was not received for evaluation, the root cause could not be determined.

• Brand Name: ASSEMBLY, BLOCK, 3.0/4.0MM CANNULATED HEADLESS
• Type of Device: 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: 16049571
• MDR Text Key: 308197059
• Report Number: 2027754-2022-00213
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 316-1350
• Device Catalogue Number: 316-1350
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1