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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
This follow-up report is being submitted to relay additional information.
Additional 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
• Common Device Name: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9602290
• Report Number: 0001032347-2020-00076
• Device Sequence Number: 16700455
• Product Code: DZL
• UDI-Device Identifier: 00841036128098
• UDI-Public: 00841036128098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention