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

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).G3: foreign source: germany d10 ¿ medical products item# 76-2601 lot# unk, ribfix blu system 8 hole straight plate.Item# 76-2602 lot# unk, ribfix blu system 12 hole prebent plate.Item# unk, lot# unk, unknown screw qty 14.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2024-00070, 0001032347-2024-00072, 0001032347-2024-00073, 0001032347-2024-00074, 0001032347-2024-00075, 0001032347-2024-00076, 0001032347-2024-00077, 0001032347-2024-00078, 0001032347-2024-00079, 0001032347-2024-000780, 0001032347-2024-000781, 0001032347-2024-000782, 0001032347-2024-000783, 0001032347-2024-000784, and 0001032347-2024-000785.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.

Event Description

It was reported that after initial implantation of plates and screws the implants loosened.The surgeon had reattached one of the plates several times.The surgeon was informed about the possible loosening of implants and the off-label use during the repeated insertion.He refused to use a new plate and reinserted the 8-hole plate.There was a 45-minute delay during the procedure.According to ct images, both plates are now torn out and need to be revised.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: RIBFIX BLU SYSTEM 12 HOLE PREBENT 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18821275
• MDR Text Key: 336735706
• Report Number: 0001032347-2024-00071
• Device Sequence Number: 1
• Product Code: HRS
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 76-2602
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2024
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 50 YR
• Patient Sex: Male