MAUDE Adverse Event Report: BIOMET 3I TITANIUM HEXED UNISCREW; DENTAL SCREW

Catalog Number UNIHT

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2021-00974.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Doctor reports implant and prosthetic screw fractured on dental position: #46 without any negative effect on the patient.The implant was removed.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).One osseotite® 2 implant 3.75 x 10mm (xfos310) and one titanium hexed uniscrew (uniht) were returned for investigation.Visual inspection of the as returned products identified both implant and screw fractured at the middle threads.Additionally, some bone debris were present on the external threads.Device history record (dhr) review could not be performed for uniht without relevant lot information.A complaint history review by item number was conducted for the (uniht) dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported devices for similar event using keyword category (fracture screw & fracture implant).Therefore, based on the available information, the reported device malfunction did occur and the event was confirmed.

Event Description

No further event information is available at the time of this report.

• Brand Name: TITANIUM HEXED UNISCREW
• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11977537
• MDR Text Key: 255955681
• Report Number: 0001038806-2021-00975
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNIHT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR