MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU 16 HOLE PREBENT PLT; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	03/15/2021
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: 0001032347-2021-00245.Concomitant medical products: ribfix system 8 hole straight plate, part# 76-2601, lot# ni report source: (b)(6).
Event or Problem 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.
Additional Manufacturer Narrative
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 b5, h2, and h10.
Event or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Correct data: d2, d4 this report is being submitted to update additional information in section b4, b5, g3, g6, h2, and h10.
Event or Problem Description
No further event informed is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Product was not returned or pictures provided; visual and dimensional evaluations could not be performed.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: RIBFIX BLU 16 HOLE PREBENT PLT
• Common Device Name: 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: 11779816
• Report Number: 0001032347-2021-00246
• Device Sequence Number: 14410711
• Product Code: HRS
• UDI-Device Identifier: 00888233001335
• UDI-Public: (01)00888233001335
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/14/2022

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: 76-2603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/11/2021; 12/31/2021; 04/13/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/08/2021; 01/07/2022; 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male