MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING 2.4 X 12MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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: 0001032347-2020-00394.Concomitant medical products: ribfix blu system 12 hole pre-bent plate, part#: 76-2602, lot#: ni.Ribfix blu system screw, self-drilling, cancellous x-drive locking 2.4 x 12mm, part#: 76-2412, lot#: ni.Fiberwire, part#: ni, lot#: ni, manufactured by arthrex.
Event or Problem Description
It was reported the patient¿s rib split during implantation of rib fixation plate and screws.The plate and screws were left in place and the rib was stabilized with fiberwire.No revision surgery is planned at this time.No additional patient consequences have been provided.
Event or Problem Description
It was reported the patient¿s rib split during implantation of rib fixation plate and screws.The existing plate was replaced with a longer plate.A suture was wrapped around the middle of the rib split and the plate for added stabilization.No revision surgery is planned at this time.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A2 patient is in his 50¿s.
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 12MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10457423
• Report Number: 0001032347-2020-00395
• Device Sequence Number: 17057913
• Product Code: HRS
• UDI-Device Identifier: 00888233001243
• UDI-Public: 00888233001243
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 76-2412
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/20/2020; 01/21/2021
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/11/2020; 01/28/2021
• 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