MAUDE Adverse Event Report: BIOMET MICROFIXATION STERILE TRAC SYSTEM STERILE TRAC XD THINFLAP 1.5 X 4.0MM 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	08/22/2019
Type of Reportable Event	Serious Injury
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 the screw tip fractured during use and resulted in a retained foreign body in the patient.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event could not be confirmed due to the product not being returned.Functional testing and inspections could not be performed due to the product not being returned and no photographs being provided.The dhr was reviewed and there are no nonconformance's found.This is the only complaint in regards to the screw fracturing for sp-st-6704 lot 355910.For this part (sp-st-6704) and the previous one year (from the notification date) regarding the fracturing of this screw, (b)(4), which is no greater than the occurrence listed in the application fmea.The most likely underlying cause cannot be determined.If any further information is found which would change or alter and conclusion or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor trends.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: STERILE TRAC SYSTEM STERILE TRAC XD THINFLAP 1.5 X 4.0MM SCREW
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9582398
• Report Number: 0001032347-2020-00055
• Device Sequence Number: 16955192
• Product Code: JEY
• UDI-Device Identifier: 00841036177959
• UDI-Public: 00841036177959
• 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): 04/15/2020

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: 04/08/2024
• Device Model Number: N/A
• Device Catalogue Number: SP-ST-6704
• Device Lot Number: 355910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 04/15/2020
• 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