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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was lying in bed and when he turned to his left side, he heard and felt a crack.Subsequently, a revision was performed due to a fractured plate.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D10: concomitant medical product - zimmer biomet ribfix blu 12 hole prebent plate catalog#: 76-2602 lot#: unknown; zimmer biomet ribfix blu 16 hole prebent plate catalog#: 76-2603 lot#: unknown.G2: foreign - germany.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: 0001032347-2023-00119 and 0001032347-2023-00121.
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.H3: other - no product was returned and insufficient information was provided.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap chest dated 10/13/22 demonstrates malleable plate and screw fixation involving three separate ribs along the inferior right hemithorax.Two scout images of the chest from a chest ct demonstrate fractured appearance of the superior most right rib malleable plate device.Overall fit and alignment of the three malleable plate right rib fixation devices are appropriate in size and alignment with eventual fracture of the superior most plate on the ct scan images.No signs of loosening, wear, or radiolucency.No contributing factors are identified.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : see h10 narrative.
Event or Problem Description
It was reported that the patient was lying in bed and when he turned to his left side, he heard and felt a crack.Subsequently, a revision was performed due to a fractured plate and constant pain.No additional information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the three returned plates.All three plates show signs of attempted using including marking scratching on the plater surface.One of the two 76-2603 plates has fractured.The remaining 76-2603 plate is still intact.The returned 76-2602 plate has fractured as well.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause has not changed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: RIBFIX BLU 16 HOLE PREBENT PLATE
• 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16683243
• Report Number: 0001032347-2023-00120
• Device Sequence Number: 12569198
• Product Code: HRS
• UDI-Device Identifier: 00888233001359
• UDI-Public: (01)00888233001359(10)J6896140
• 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: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/27/2023

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
• Device Lot Number: J6896140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 04/06/2023; 09/20/2023; 10/25/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/04/2023; 09/27/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 76 KG