MAUDE Adverse Event Report: BIOMET MICROFIXATION "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: zimmer biomet tmj system right narrow mandibular component, 45 mm, catalog #: 01-6545, lot #: 859610a.Zimmer biomet tmj system left narrow mandibular component, 45 mm, catalog#: 01-6546, lot#: 787750c.Zimmer biomet tmj system right fossa component, small, catalog#: 24-6562, lot#: 857280b.Zimmer biomet "2.4mm" system high torque (ht) cross-drive screw, catalog#: 91-2708.Zimmer biomet tmj system left fossa component, small, catalog#: 24-6563, lot#: 882250c.Zimmer biomet tmj system cross drive emergency fossa screw, catalog#: 99-6587.Zimmer biomet tmj system cross drive fossa screw, catalog#: 99-6577.Zimmer biomet "2.4mm" system high torque (ht) cross-drive screw, catalog#: 91-2710.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00318, 0001032347-2019-00319, 0001032347-2019-00320, 0001032347-2019-00321, 0001032347-2019-00322, 0001032347-2019-00324, and 0001032347-2019-00325.

Event Description

It was reported that the patient developed a hematoma and infection post operatively.As a result, the implants were removed eleven days after implantation.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.As a revision occurred, the complaint is confirmed.Functional testing and inspections could not be performed due to the parts not being returned and no photographs, x-rays, ct scans, or physician reports being provided.The dhrs for the screws could not be reviewed due to the lot numbers being unknown.There are no indications of manufacturing defects.For all 2.7x10mm ht x-drive screw (part# 91-2710) in the previous year (from the notification date), there is a complaint rate of 0.46%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint cannot be determined.There are no indications of manufacturing defects.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.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8692579
• MDR Text Key: 147777578
• Report Number: 0001032347-2019-00323
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036053642
• UDI-Public: 00841036053642
• Combination Product (y/n): N
• PMA/PMN Number: K001238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-2710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 11 YR