MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SCR S/D-LK 2.4X12MM; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that the patient underwent an initial surgery during which the surgeon cut both ends of the plates and fixed with two screws.Subsequently, the plates and unknown quantity of screws were removed due to poor fixation.
Additional Manufacturer Narrative
Complaint (b)(4).D10 ¿ medical products item #76-2408, lot #j7660149; ribfix blu scr s/d-lk 2.4x8mm; qty 1.Item #76-2408; lot #j7690448; ribfix blu scr s/d-lk 2.4x8mm; qty 3.Item #76-2412, lot #040670; ribfix blu scr s/d-lk 2.4x12mm; qty 2.Item #76-2412, lot #933640 ribfix blu scr s/d-lk 2.4x12mm; qty 6.Item # 76-2601, lot #j7720232; ribfix blu 8 hole straight plt; qty 2.G2: foreign source: japan.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 or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h4, h6, h10, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is unconfirmed.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.

• Brand Name: RIBFIX BLU SCR S/D-LK 2.4X12MM
• Common Device Name: SCREW, 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: 21047972
• Report Number: 0001032347-2024-00406
• Device Sequence Number: 16996551
• Product Code: HWC
• UDI-Device Identifier: 00888233001243
• UDI-Public: (01)00888233001243(10)933640
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 76-2412
• Device Lot Number: 933640
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown