MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00168, 0001032347-2020-00170.Concomitant medical products: 1.5 lactosorb system straight plate - 4 hole, part# 915-2413, lot# 846820; 2.0 lactosorb system straight plate - extended - 4 hole, part# 915-2111, lot# 144990; 2.0 lactosorb system l-shape plate - left extended, part# 915-2151, lot# 957040.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 that three (3) bio-absorbable plates were removed due to infection approximately two (2) weeks following implantation during a midface reconstruction procedure.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.As there is a reported revision surgery the complaint is considered confirmed.Functional testing could not be conducted as the products were not returned.Per customer provided follow up it is unknown if the infection is related to the device or what the cause of the infection is.The dhr and sterilization certificates were reviewed and there were no non-conformances found.There are no indications of manufacturing defects.For this part (915-2111) and the previous one year (from the notification date) regarding a revision surgery due to infection, there is a complaint rate of 0.03% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause could not be determined due to insufficient information provided to determine the failure mode that led to the infection.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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: 2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9853284
• Report Number: 0001032347-2020-00169
• Device Sequence Number: 3331998
• Product Code: HRS
• UDI-Device Identifier: 00841036054564
• UDI-Public: 00841036054564
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2023
• Device Model Number: N/A
• Device Catalogue Number: 915-2111
• Device Lot Number: 144990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 37 YR