MAUDE Adverse Event Report: BIOMET MICROFIXATION STERILE TRAC SYSTEM SELF-DRILLING, HIGH-TORQUE SCREW; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (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 a screw fractured upon insertion.No adverse events were reported as a result of this malfunction.
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 confirmed.The ster trac 1.5x4.0mm ht screw (part# 15-6104, lot# 045630) was returned for investigation.A visual inspection was conducted.The screw tip shows signs of wear.Functional testing was completed by attempting to insert the screw in a piece of white oak wood using a 01-7390 driver handle lot 048760 with a 15-1196 1.5mm bit lot number 406650.When an attempt was made to turn the screw into the wood the screw tip was unable to penetrate the wood surface.The dhr was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.For this part (15-6104) and the previous one year (from the notification date) regarding the fracturing of this screw, there is a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is excessive force applied during an insertion attempt, beyond what the implant is designed to encounter.It is possible that the fracture occurred due to over torqueing, an off axis insertion attempt, or attempting to insert the screw into a patient with high bone density.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.The following fields were updated: b4 date of this report, b5 describe event or problem, d10 device availability, g4 date received by manufacturer, g7 type of report, h2 follow up type, h3 device evaluated by manufacturer, h6 method code, h6 results code, h6 conclusions code, and h10 additional narratives/data.

• Brand Name: STERILE TRAC SYSTEM SELF-DRILLING, HIGH-TORQUE SCREW
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9420696
• Report Number: 0001032347-2019-00527
• Device Sequence Number: 1712143
• Product Code: JEY
• UDI-Device Identifier: 00841036147686
• UDI-Public: 00841036147686
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972322
• 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): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 15-6104
• Device Lot Number: 045630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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