MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING 2.4 X 10MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2019
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: 0001032347-2020-00537, 0001032347-2020-00539.Medical products custom made device gomez custom chest recon plate, part# cp-3043, lot# 888560.Ribfix blu system screw, self-drilling, cancellous x-drive locking 2.4 x 8mm, part# 76-2408, lot# ni.Ribfix blu system screw, self-drilling, cancellous x-drive locking 2.4 x 10mm, part# 76-2410, lot# ni.
Event or Problem Description
It was reported that several broken screws were discovered during follow-up more than one (1) year following implantation of a custom chest reconstruction prosthesis.The patient is asymptomatic and exhibits no significant shortness of breath or chest pain.Follow up x-rays revealed broken screws used to anchor the most inferior portion of the implant to the posterior aspect of the right 7th rib.A subsequent ct scan suggests that several of these screws have minimal purchase on the underlying rib.The screws that fractured were the distal 3rd, 4th and 5th screws on the 7th rib.The posterior portion of the rib prosthesis is currently sitting 3-4mm off of the native rib, but the anterior section is still positioned appropriately with two points of fixation.The surgeon states that he does not believe this is a failure of the implant as it remains in excellent position and is achieving the stated goal to correct the deformity.The surgeon also stated that there is no reason to re-operate at this time and the patient does not appear to be harmed in any way by the broken screws.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.A definitive root cause cannot be determined.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
No further event information available at the time of this report.

• Brand Name: RIBFIX BLU SYSTEM SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING 2.4 X 10MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10771719
• Report Number: 0001032347-2020-00538
• Device Sequence Number: 1926867
• Product Code: HRS
• UDI-Device Identifier: 00841036184209
• UDI-Public: 00841036184209
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 76-2410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 04/12/2021
• 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: Required Intervention
• Patient Age: 12 YR