MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING; 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).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has been received by zimmer biomet and 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: 0001032347-2019-00424, 0001032347-2020-00023.The patient is approximately (b)(6).Medical products: ribfix blu system 24 hole pre-bent plate, part# 76-2604, lot# unk, ribfix blu system screw, self-drilling, cancellous x-drive locking, part# 76-2412, lot# unk, ribfix blu system screw, self-drilling, cancellous x-drive locking, part# 76-2414, 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 (b)(6) 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 (b)(6), sales rep reports that the 3rd ribfix plate broken in association w/ past cmp.The previous cmp referenced and the corresponding pce are both attached.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 on (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 (76-2412) and the previous one year (from the notification date) regarding the fracturing of this plate, (b)(4).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 SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9547264
• Report Number: 0001032347-2020-00022
• Device Sequence Number: 2334231
• Product Code: HRS
• UDI-Device Identifier: 00841036197872
• UDI-Public: 00841036197872
• 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,u
• 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: 76-2412
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/03/2020
• 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