MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.6MM LARGE ANGLE PLATE, STRAIGHT; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/22/2019
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.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.Medical products: unknown screws, part# unk, lot# unk.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 a reconstruction plate fractured eighteen months after implantation.The plate was originally implanted with no bone graft.The fractured plate was removed in a revision and a new plate was implanted.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.A visual inspection was conducted on the plate and heavy wear could be seen on its surface.Multiple wear marks/ indentations could be seen on the plate surface.The plate has fractured into two pieces.The dhr will not be reviewed as the lot number remains unknown.There are no indications of manufacturing defects.For this part (44-1023) and the previous two years (from the notification date) regarding the plate fracturing, there is a complaint rate of 0.43%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause is excessive force causing the plate to fracture and a lack of a bone graft as indicated by the customer.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 2.6MM LARGE ANGLE PLATE, STRAIGHT
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9537005
• Report Number: 0001032347-2019-00591
• Device Sequence Number: 14300176
• Product Code: JEY
• UDI-Device Identifier: 00841036130558
• UDI-Public: 00841036130558
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K063052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 44-1023
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 05/28/2020
• 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