MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE LEFT, MEDIUM, 0.6MM; PLATE, BONE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint: (b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00114, 0001032347-2020-00115, 0001032347-2020-00116, 0001032347-2020-00117, 0001032347-2020-00118.Concomitant medical products: 1.5mm system plate l-shape, 3 x 3 hole, 100 degree left, medium, 0.6mm, part# 01-7032, lot# unk, 1.5mm system plate l-shape, 3 x 3 hole, 100 degree right, medium, 0.6mm, part# 01-7033, lot# unk, 1.5mm system high torque (ht) cross-drive screw, 5/pk, part# 95-1504, lot# unk, 1.5mm system high torque (ht) cross-drive screw, 5/pk, part# 95-1505, lot# unk, unknown le fort plate, part# unk, lot# unk.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(4).
Event or Problem Description
It was reported the left plates fractured and the right plates loosened approximately one year post-operatively following a le fort i osteotomy.A revision was performed to remove the plates and screws.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The event was initially reported with no part number given for a le fort plate, and the part number was provided at a later date.D11 ¿ medical products 1.5mm system lefort plate, flat 0.6mm, part# 01-6480, lot# unk.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.The products were returned for investigation.The implants showed signs of use.They were discolored, bent, and fractured, which is consistent with the complaint that they had failed post-operatively.It was reported that both left plates were broken after the operation and loosening also occurred on the right side.The two left plates were confirmed to be fractured.The reported right side loosening could not be verified from the information provided, as no x-rays, scans, or physician's reports were received.It was unclear if the reported loosening was in regards to the interface between the screws and patient's bone or the interface between the plate and screws.The dhr could not be reviewed due to the lot number being unknown.There are no indications of manufacturing defects.For this part (01-7032) and the previous one year (from the notification date) regarding a plate fracture or loosening, there is a complaint rate of 0.15% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint could not be determined.It is possible that the patient's activity level weakened the implants, causing the fractures and loosening.It is also possible that the plates were weakened while bending during the initial surgery, either by over-bending or bending back and forth repeatedly.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: b4 date of this report.B5 describe event or problem.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.

• Brand Name: 1.5MM SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE LEFT, MEDIUM, 0.6MM
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9726871
• Report Number: 0001032347-2020-00114
• Device Sequence Number: 2101147
• Product Code: JEY
• UDI-Device Identifier: 00841036012465
• UDI-Public: 00841036012465
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2020

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: 01-7032
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 02/18/2020; 07/28/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/11/2020; 07/29/2020
• 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
• Patient Age: 38 YR