MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.4 MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7 X 8 MM; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00143 through 0001032347-2019-00148.
Event or Problem Description
It was reported by the patient that a revision was performed due to a persistent staphylococcus infection.The patient is on iv antibiotics and an antibiotic impregnated spacer was implanted.New implants will be placed in approximately one month.The patient advises the spacer keeps popping out and she is experiencing bad headaches.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of evidence that the revision was performed.No product was returned, therefore no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.Because a revision surgery occurred, the complaint is considered to be confirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00143-1, 0001032347-2019-00144-1, 0001032347-2019-00146-1, 0001032347-2019-00147-1, 0001032347-2019-00148-1.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: 2.4 MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7 X 8 MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8394432
• Report Number: 0001032347-2019-00145
• Device Sequence Number: 14200410
• Product Code: HWC
• UDI-Device Identifier: 00841036053635
• UDI-Public: 00841036053635
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K113512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-2708
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention