MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 1.5/0.6MM, L PLATE, 100 DEGREE, 10MM, LEFT; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/28/2019
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 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: 0001032347-2020-00066.Medical products: traumaone system 1.5/0.6mm, l plate, 100 degree, 10mm, right, part# sp-3210-r, lot# unk, traumaone system 1.5/0.6mm, l plate, 100 degree, 10mm, left, part# sp-3210-l, lot# unk, unknown screws, part# unk, lot# unk.
Event or Problem Description
It was reported that plates fractured post-operatively and were removed in a revision.The patient had a bruxing habit that may have contributed to the fracture.The hardware and fractured plates were removed in a revision.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.As there was a revision surgery, the complaint is confirmed.The two (2) 1.5/.6mm l plt 100d 10mm left (part# sp-3210-l, lot# unk) were not returned for investigation; therefore, no visual inspections or functional testing could be conducted.No scans, x-rays, pictures, of physician's reports were provided.The dhrs and the non-conformance database could not be reviewed for these parts as the lot numbers remain unknown.There are no indications of manufacturing defects.For this part (sp-3210-l) and the previous five years (from the notification date) regarding the fracturing of this plate, there is a complaint rate of 0.92% which is greater than the occurrence listed in the application fmea.Because this is an isolated incident with a product with low sales, the exceeded occurrence rate does not require an update to the risk assessment document.The most likely underlying cause of the complaint is patient activity as it was reported the patient had a bruxing habit.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 1.5/0.6MM, L PLATE, 100 DEGREE, 10MM, LEFT
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9592067
• Report Number: 0001032347-2020-00067
• Device Sequence Number: 11381223
• Product Code: JEY
• UDI-Device Identifier: 00841036185428
• UDI-Public: 00841036185428
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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-3210-L
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 06/29/2020
• 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