MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB SYS L-PLT LT LRG 2.0; SCREW, FIXATION, BONE

Model Number	N/A
Health Effect - Clinical Codes	Impaired Healing (2378); Skin Tears (2516); Swelling/ Edema (4577)
Date of Event	04/27/2022
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.
Event or Problem Description
It is reported that the patient was revised due to plate exposure while suffering from sinusitis.The patient is not infected, and the size of the exposure was about 1.5 cm x 1.5 cm.The wound was left open to assist in treatment of the sinusitis.The patient is scheduled to have the exposed area closed at a later date.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section b4, b5, d6, g3, g6, h2, h6 and h10.
Event or Problem Description
It has been further reported that the patient has not been revised of the implant to date.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This report is being submitted to update additional information in section b4, b5, d4, g3, g6, h2, h3, h4, h6 and h10.

• Brand Name: LACTOSORB SYS L-PLT LT LRG 2.0
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14515788
• Report Number: 0001032347-2022-00169
• Device Sequence Number: 12400108
• Product Code: HRS
• UDI-Device Identifier: 00841036054670
• UDI-Public: (01)00841036054670(17)260212(10)062300
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2022

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 Expiration Date: 02/12/2026
• Device Model Number: N/A
• Device Catalogue Number: 915-2151
• Device Lot Number: 062300
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2022
• Supplement Date Received by Manufacturer: 05/30/2022; 07/29/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/27/2022; 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown