MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM 2.0 X 5 MM LACTOSORB SCREW; PLATE, BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The user facility is foreign; therefore, a facility medwatch report will not be available.(b)(6).

Event Description

It was reported the screw fractured during insertion.The screw slipped during implantation and could not be inserted, and then the screw head fractured.No adverse events have been reported as a result of the malfunction.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in section d4, h2, h3, h6 and h10.

• Brand Name: 2.0 LACTOSORB SYSTEM 2.0 X 5 MM LACTOSORB SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10786250
• MDR Text Key: 214755504
• Report Number: 0001032347-2020-00559
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036055004
• UDI-Public: 00841036055004
• Combination Product (y/n): N
• PMA/PMN Number: K002083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2024
• Device Model Number: N/A
• Device Catalogue Number: 915-2300
• Device Lot Number: 370090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 30