MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU 24 HOLE PREBENT PLT; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00265.Medical products: ribfix blu system 16 hole pre-bent plate, part# 76-2603, lot# ni.Report source ¿ (b)(6).
Event or Problem Description
It was reported that two (2) rib plates on ribs eight (8) and nine (9) fractured post-operatively.The patient previously underwent an osteosynthetic stabilization of rib six (6) through nine (9) twelve weeks ago following multiple rib fractures.The plates on ribs seven (7) and eight (8) have fractured previously and been replaced in a revision nine (9) weeks ago.A revision is expected following discussion with the patient but no revision is currently planned.It was reported that no further information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records and radiographs were provided and reviewed by health care professionals.Radiologist review of the "three images of the chest demonstrate plate and screw fixation of the left sixth through ninth ribs laterally.There is fractured appearance of the left seventh through ninth rib plates.Overall fit and alignment of the implants is appropriate.Limited evaluation for bone quality.No signs of loosening, radiolucency.No contributing factors are seen." the fractured plates were discovered (b)(6)2021.No revision has been reported to date, however, they are currently still in discussion with patients on course of treatment.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.

• Brand Name: RIBFIX BLU 24 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: 11847802
• Report Number: 0001032347-2021-00266
• Device Sequence Number: 14258847
• Product Code: HRS
• UDI-Device Identifier: 00888233001359
• UDI-Public: (01)00888233001359
• 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
• 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
• Report Date (Section B): 03/22/2022

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: 76-2604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 03/23/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male