MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM 12 HOLE PRE-BENT PLATE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; 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: 0001032347-2021-00010.Concomitant medical products ribfix blu system 12 hole pre-bent plate, part# 76-2602, lot# ni, zimmer biomet.Ribfix blu system screw, self-drilling, cancellous x-drive locking 2.4 x 10mm, part# 76-2410, lot# ni, zimmer biomet.Dynagraft ii, part# 02-2000-050, lot# 161227, isotis orthobiologics.Initial reporter occupation ¿ patient.
Event or Problem Description
It was reported a patient underwent a revision to remove a rib plate two years following implantation due to plate fracture and pain.Two years ago, the patient was implanted with a rib plate during an open reduction and internal fixation of a rib fracture with non-union on the left 11th rib.The patient experienced constant pain following implantation.The surgeon discovered the plate was fractured and removed the plate and rib bone.The patient now describes his condition as great.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
No product was 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.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar complaints for the reported item.However, as the lot number is unknown, an additional review could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records confirmed revision for fracture.The implants were sent to pathology and were not available to be returned for investigation.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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
This follow-up report is being submitted to relay additional information.

• Brand Name: RIBFIX BLU SYSTEM 12 HOLE PRE-BENT PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11121473
• Report Number: 0001032347-2021-00009
• Device Sequence Number: 632033
• Product Code: HRS
• UDI-Device Identifier: 00841036184315
• UDI-Public: 00841036184315
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2021

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: 76-2602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/08/2021; 09/27/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/02/2021; 09/30/2021
• 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 Weight: 109