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	Foreign Body In Patient (2687)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional 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.Report source: (b)(6).
Event or Problem Description
It was reported a screw fractured upon insertion.A screw fragment remained in the patient resulting in retention of a foreign body.No additional patient consequences have been reported.
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# 577340) was returned for investigation.A visual inspection was conducted.The screw shows signs of use as there was marking on screw head.The screw arrived fractured near the base of the head.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 0.08% 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 h10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• 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: 9420688
• Report Number: 0001032347-2019-00524
• Device Sequence Number: 2490906
• 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
• Device Implanted Year: 2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 15-6104
• Device Lot Number: 577340
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/25/2020
• 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