MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.0X7MM SELF-DRILLING IMF SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number N/A

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

Patient Problem Bone Fracture(s) (1870)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Report source ¿ (b)(6).

Event Description

It was reported the intermaxillary fixation screw was difficult to remove.The patient's bone chipped when the surgeon pushed in hard.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is unconfirmed.A visual inspection of the screws showed light signs of use but overall the screws were in good working condition.Function testing was completed by inserting the screws into a testing driver handle 01-7390 lot 048760 functionally tested with 46-0011 blade lot 646650.Both screws were fully retained by the blade and then were inserted into a piece of white oak.The screws were able to penetrate the white oak fully and functioned as intended.The dhr was not reviewed as the lot number remains unknown.For this part (91-5607) and the previous one year (from the notification date) regarding an idle screw, there is a complaint rate of 0.02%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause cannot be determined as the complaint could not be recreated however excessive force being applied to the screw and handle could have potentially led to the bone chipping.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.

• Brand Name: TRAUMAONE SYSTEM 2.0X7MM SELF-DRILLING IMF SCREW
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9602290
• MDR Text Key: 175415481
• Report Number: 0001032347-2020-00076
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00841036128098
• UDI-Public: 00841036128098
• Combination Product (y/n): N
• PMA/PMN Number: K983728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

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
• Device Model Number: N/A
• Device Catalogue Number: 91-5607
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention