MAUDE Adverse Event Report: BIOMET 3I UNK BIOMET SCREW; DENTAL SCREW

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Weight unknown / not provided.Brand name unknown / not provided.Catalog and lot number unknown / not provided.Email address and fax number unknown / not provided.Pma/510(k) number not available.Device manufacture date not available.

Event Description

It was reported that the screw fractured and was removed from the implant.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4) the following sections have been updated: b4: date of this report b5: describe event or problem h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes h10: additional narrative two (2) unknown lb screws were returned for investigation.Visual evaluation of the as returned product identified both pieces were returned with signs of wear.Both screws can be seen fractured.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 devices were located on an unknown tooth site (fdi) and were used for approximately 3 years 2 months.The customer did not provide any pictures or x-rays.Documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019.Information identified: potential adverse events; page 1.Per the applicable ifu, breakage may occur when device is loaded beyond its functional capability.Dhr and complaint history review could not be performed since the lot/item numbers were unknown.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.January post market trending was reviewed and there were no actionable events or corrective actions for the reported event (screw fracture) or products (unknown lb screw).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed as physical evaluation identified the fractured screws.

Event Description

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

• Brand Name: UNK BIOMET SCREW
• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11102137
• MDR Text Key: 224592716
• Report Number: 0001038806-2020-02171
• 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
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR