MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).Weight unknown / not provided.Brand name unknown / not provided.Device product code unknown / not provided.Catalog and lot number unknown / not provided.Pma/510(k) number not available.

Event Description

It was reported that when doctor was taking impressions the screw fractured inside the implant and was not possible to remove the fractured portion.Doctor removed the implant and placed another one.

Event Description

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

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem d9: device availability g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative one 3i t3® non-platform switched tapered implant 4 x 11.5mm (bost411) returned for investigation.Visual inspection of the as returned products identified one implant with fractured screw inside of it.Additionally, some external thread featured identified to have minor scratches.Device history record (dhr) and complaint history review could not be performed for unknown lb screw as the lot/item number was not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Therefore, based on the available information, the reported device malfunction (screw fracture) did occur and was confirmed.

• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11054102
• MDR Text Key: 223067515
• Report Number: 0001038806-2020-02107
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• 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: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR