MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.0X5MM CROSS-DRIVE SCREW; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/06/2020
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.The device will not be returned for analysis as it remains implanted; 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: 0001032347-2020-00083.Medical products: traumaone system 4 hole straight w/gap 1.0mm plate, part# 42-1004, lot# unk, traumaone system 2.0x5mm cross-drive screw, part# 41-2005, lot# unk.
Event or Problem Description
It was reported the patient developed an infection in the lower left jaw four months post-operatively following a sagittal split ramus osteotomy.The surgeon believed the infection was due to a loosening of the plate.A month after the infection was discovered, a re-operation occurred and the plate was re-fixed.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed as post-operative intervention was reported.Product was not returned for investigation and no photos, scans, x-rays, or physician's reports were provided.For these reasons, no inspections or functional testing could be conducted.The dhr could not be reviewed due to the lot number remaining unknown.There are no indications of manufacturing defects.For this part (41-2005) and the previous one year (from the notification date) regarding the loosening of this screw or an infection, there is a (b)(4)which is no greater than the occurrence listed in the application fmea.It was reported that the cause of the infection was likely the loosening of the plate and bone fixation, however, the cause of the loosening of the plate could not be determined from the information provided.It is also possible that there was another cause of the infection and the infection led to the loosening of the plate.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: TRAUMAONE SYSTEM 2.0X5MM CROSS-DRIVE SCREW
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9661922
• Report Number: 0001032347-2020-00084
• Device Sequence Number: 3475176
• Product Code: JEY
• UDI-Device Identifier: 00841036124595
• UDI-Public: 00841036124595
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081067
• 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): 07/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 41-2005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 07/28/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention