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 Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).It is unknown at this time if the device will be returned for evaluation.The product remains implanted in the patient, but a revision may occur at a later unspecified date at which time the device may be returned for testing.The investigation is in process.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: 0001032347-2019-00397, 0001032347-2019-00398.Date of event occurred in early (b)(6) 2019.The user facility is foreign; therefore a facility medwatch report will not be available.Report source¿ (b)(6).
Event or Problem Description
It was reported that a rib plate on rib number (8) eight fractured post-operatively following the open reduction and internal fixation of ribs (8) eight, (9) nine, and (10) ten.The plates remain implanted.Ct scans will be performed at a later date, at which time it will be decided if or when the fractured plate will be explanted.No additional patient consequences were reported.
Event or Problem Description
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.Due to the lack of photos, scans, x-rays, and physician's reports for the fractured plate and the fact that no revision surgery was confirmed, the complaint cannot be verified.The complaint was opened because roshan hall, sales rep reports ribfix fracture and revision surgery planned.The ribfix blu 12 hole prebent plt (part# 76-2602, lot# unk, qty 3), ribfix blu scr s/d-lk 2.4x12mm (part# 76-2412, lot# unk, qty 28), and ribfix blu scr emg-lk 2.7x12mm (part# 76-2712, lot# unk, qty 1) were not returned for investigation as they remain implanted.The surgeon originally plated ribs 8, 9, and 10 posteriorly on may 23, 2019.It was reported that the plate on rib 8 fractured at the site of the original rib fracture following excessive coughing due to a cold in early june 2019.It was also reported that the patient was an obese male, which may have also contributed to the device fracture.The dhr's for these products could not be reviewed due to the lot numbers being unknown.There are no indications of manufacturing defects.For this part (76-2602) and the previous one year (from the notification date) regarding the fracturing of this plate, there is a complaint rate of 0.089%, which is no greater than the occurrence listed in the application fmea.This file is not being submitted for clinical review due to the lack of information reported in the case.The most likely underlying cause could not be determined, though it is possible that the fracture is due to the mentioned patient conditions.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.

• 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: 8938131
• Report Number: 0001032347-2019-00396
• Device Sequence Number: 13607428
• Product Code: HRS
• UDI-Device Identifier: 00841036184315
• UDI-Public: 00841036184315
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: 07/29/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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