MAUDE Adverse Event Report: BIOMET 3I CERTAIN® GOLD-TITE® HEXED SCREW; ABUTMENT SCREW

Catalog Number IUNIHG

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Weight unknown / not provided, email address unknown / not provided.

Event Description

Doctor indicated fracture of the iunihg abutment screw.

Manufacturer Narrative

One certain® gold-tite® hexed screw (iunihg) was returned for investigation.Visual inspection of the as returned product identified fracture confirmed at the threaded region.Therefore, based on the evaluation, device malfunction did occur and the reported event was confirmed following inspection.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.A device history review was performed and no related nonconformance¿s were noted.Also a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.A singular root cause could not be determined.The following sections have been updated: expiration date, udi: (b)(4).Device evaluated by manufacturer: change "no" to "yes.".

Event Description

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

• Brand Name: CERTAIN® GOLD-TITE® HEXED SCREW
• Type of Device: ABUTMENT SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8203548
• MDR Text Key: 131744223
• Report Number: 0001038806-2018-01059
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/13/2023
• Device Catalogue Number: IUNIHG
• Device Lot Number: 1214090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• Patient Sequence Number: 1
• Patient Age: 56 YR