MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM 24 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).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.See mdr report 0001032347-2019-00366.For details for the related event ((b)(4)).The patient is approximately (b)(6).Medical products: unknown screws 2.4mm, cat# unk, lot# unk; unknown screws 2.7mm, cat# unk, lot# unk.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 one rib plate was found fractured during the removal of a further two fractured rib plates.The patient suffered rib fractures following a motor vehicle accident approximately three years ago.In (b)(6) 2019, three plates were used during the open reduction and internal fixation of the sixth, seventh and eighth ribs.In late may or early (b)(6) 2019, the rib plates on ribs six and seven were confirmed fractured by x-ray imaging.At a later unspecified date, the third rib plate on rib eight fractured.A revision surgery removed all three fractured plates and corresponding screws.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.The complaint was opened because roshan hall, sales rep reports that the 3rd ribfix plate broken in association with a past complaint the three (3) ribfix blu 24 hole prebent plt (part# 76-2604, lot# unk), twenty (20) ribfix blu scr s/d-lk 2.4x12mm (part# 76-2412, lot# unk), and four (4) ribfix blu scr s/d-lk 2.4x14mm (part# 76-2414, lot# unk) were returned for investigation.The investigation of the previous complaint concluded that these three plates were fixed to ribs 6, 7, and 8 and that the plates on ribs 6 and 7 had fractured.These two plates fractured in (b)(6) 2019.On (b)(6) 2019, the third plate located on rib 8 also fractured and all of the implants were explanted.The dhr(s) for these plates could not be reviewed due to the lot numbers being unknown.There are no indications of manufacturing defects.For this part (76-2604) and the previous one year (from the notification date) the fracturing of this plate, there is a complaint rate of 0.209% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause cannot be determined from the information provided.The sales rep mentioned more screws on the immediate left and right of the fractures would have provided more structural integrity.It is also possible that the previous two plate fractures placed additional stresses on the third plate over the course of approximately three months and contributed to the fracture of that device.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.The following fields were updated: b4 date of this report b5 describe event or problem d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: RIBFIX BLU SYSTEM 24 HOLE PRE-BENT PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9167646
• Report Number: 0001032347-2019-00424
• Device Sequence Number: 2022813
• Product Code: HRS
• UDI-Device Identifier: 00841036184322
• UDI-Public: 00841036184322
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 76-2604
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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