MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX SYSTEM 8 HOLE STRAIGHT PLATE; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 02/15/2021

Event Type  Injury  

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.Patient is in her (b)(6).Concomitant medical products: unknown ribfix screw, part# ni, lot# ni.

Event Description

It was reported the rib plate fractured two (2) months post-operatively following an open reduction and internal fixation of a rib fracture.There is no revision planned at this time.It was reported no further information is available.

Event Description

No further event information available at the time of this report.

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.This report is being submitted to update additional information in section h2, h3, h6 and h10.

• Brand Name: RIBFIX SYSTEM 8 HOLE STRAIGHT PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11507489
• MDR Text Key: 245858942
• Report Number: 0001032347-2021-00122
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888233001335
• UDI-Public: (01)00888233001335
• Combination Product (y/n): N
• PMA/PMN Number: K142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 76-2601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other