MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM SUBCONDYLAR PLATE, 1.0MM, RIGHT 35.20X18.29X1.02MM; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Customer has indicated that the product will be returned to zimmer biomet for investigation after removal.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported a plate fracture was discovered two (2) days post-operatively.The right subcondylar plate was placed during an open reduction and internal fixation of a mandible fracture.The fracture was discovered by post-operative ct scan.A revision will be performed to remove the fractured implant.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.The subcondylar plate 1.0mm right (item# sp-2978, lot# unk) was returned for investigation.The plate is y-shaped and was fractured across the screw hole nearest to the joint of the three branches.The dhr for this plate could not be reviewed due to the lot number remaining unknown.There are no indications of manufacturing defects.For this part (sp-2978) in the previous two years (from the notification date) regarding the fracturing of this plate, there is a complaint rate of 0.46% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint cannot be determined from the information provided.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.The following fields were updated: b3 date of event.B4 date of this report.B5 describe event or problem.D7 explantation date.D10 device availability.G4 date received by manufacturer.G7 type of report.H2 follow up type.H3 device evaluated by manufacturer.H6 method code.H6 results code.H6 conclusions code.H10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TRAUMAONE SYSTEM SUBCONDYLAR PLATE, 1.0MM, RIGHT 35.20X18.29X1.02MM
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10383021
• Report Number: 0001032347-2020-00363
• Device Sequence Number: 2942505
• Product Code: JEY
• UDI-Device Identifier: 00888233021036
• UDI-Public: 00888233021036
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K081067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: SP-2978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 08/08/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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