MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM LEFORT PLATE, FLAT 0.6MM; PLATE, BONE

Model Number N/A

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Information (3190)

Event Date 01/16/2020

Event Type  Injury  

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)(6).

Event 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.

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.The following fields were updated: b4 date of this report b5 describe event or problem d1 brand name d2 type of the device d4 catalog and udi number d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h10 additional narratives/data.

Event Description

This follow-up report is being submitted to relay additional information.

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 (01-6480) and the previous one year (from the notification date) regarding a plate fracture or loosening, there is a complaint rate of 0.29% 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.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: 1.5MM SYSTEM LEFORT PLATE, FLAT 0.6MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9726900
• MDR Text Key: 189439892
• Report Number: 0001032347-2020-00118
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-6480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR