MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW

Catalog Number UNK BIOMET SCREW

Device Problem Fracture (1260)

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

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).Weight unknown / not provided.Brand name unknown / not provided.Catalog and lot number unknown / not provided.Concomitant medical devices: xiitp5413- osseotite® tapered certain® prevail® implant 5/4 x 13mm, lot# 2019070346.Email address unknown / not provided.Pma/510(k) number not available.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

It was reported that the screw fractured inside the implant at tooth location #5 and the implant was removed.

Manufacturer Narrative

This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: investigation type codes were added: 4111 and 4110.H6: investigation findings code was added: 3252.H6: investigation conclusions codes were added: 4307.One (1) osseotite® tapered certain® prevail® implant 5/4 x 13mm (xiitp5413) was returned for investigation.Visual evaluation of the as returned product identified the implant drive feature to have a piece of a fractured screw, the implant collar was seen fractured as well, possibly from the removal process.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was unknown bone density type.The reported device was located on tooth # 5 (universal) and was used for approximately 1 year, and 27 days.Dhr and complaint history review cannot be performed for the unknown biomet screw, without relevant item / lot number.August post market trending was reviewed and there were no actionable trends or corrective actions for the reported device and event (screw fracture).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, the reported device malfunction did occur and the reported event was confirmed, as the fractured screw was identified.

Event Description

During follow up, the customer responded stating that they have no record of the implant being fractured during placement.They believe it was damaged during removal.

• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12127956
• MDR Text Key: 260248920
• Report Number: 0001038806-2021-01183
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK BIOMET SCREW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT-SEE H10 NARRATIVE.; DENTAL IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR