MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX SYSTEM 8 HOLE STRAIGHT PLATE; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 03/15/2021

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: 0001032347-2021-00246.Concomitant medical products: ribfix system 8 hole straight plate, part# 76-2601, lot# ni.Report source foreign: (b)(6).

Event Description

It was reported two (2) rib plates were explanted three (3) weeks following implantation due to plate fracture and migration.The patient previously underwent an osteosynthetic stabilization of ribs six (6) through nine (9) following multiple rib fractures.Post discharge, the patient complained of pain in the affected area and ct scan revealed defects with plating system.The seventh (7th) rib plate was dislocated/migrated and the eighth (8th) rib plate was fractured.The plates were explanted without complication.It was reported that no further information is available.

Event Description

It was reported two (2) rib plates were explanted three (3) weeks following implantation due to plate fracture and migration.The patient previously underwent an osteosynthetic stabilization of ribs six (6) through nine (9) on the left side following multiple rib fractures.Post discharge, the patient complained of pain in the affected area and ct scan revealed defects with plating system.The seventh (7th) rib plate was dislocated/migrated and the eighth (8th) rib plate was fractured.The plates were explanted without complication.It was reported that no further information is available.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product confirmed that it had fractured at a screw hole near the center of the plate.A second plate had migrated, but there was no indication as to what treatment/surgical intervention took place and this plate was not returned for investigation.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.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.This report is being submitted to update additional information in section b4, b5, g3, g6, h2, h3, h6 and h10.

Event Description

No further event information is available at the time of this report.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Correct data: d10: medical products: ribfix blu 16 hole prebent plt, part#: 76-2603, lot#: ni.

• Brand Name: RIBFIX SYSTEM 8 HOLE STRAIGHT PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 11779808
• MDR Text Key: 254492525
• Report Number: 0001032347-2021-00245
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888233001335
• UDI-Public: (01)00888233001335
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• 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: 76-2601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male