MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX ADVANTAGE SHORT BRIDGE & 23MM POSTS; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis as it was not returned by the facility; 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: 0001032347-2020-00551.Concomitant medical products: ribfix advantage short bridge & 23mm posts, part# 323.1013, lot# ni.Ribfix advantage long bridge & 23mm posts, part# 323.1033, lot# ni.Unknown anterior rib plate, part# ni, lot# ni, unknown manufacturer.

Event Description

It was reported the rib plate post was not long enough to go through the patient's rib resulting in a three (3) hour surgical delay.The bridge post would not come through the pilot hole enough for the locking cap to engage with the threads.The surgeon drilled the pilot hole perpendicularly and was pulling up on the cable while another surgeon was applying pressure to the bridge from inside the chest.It was suggested that tissue or a callous prevented the bone from approximating.The displaced fractured was plated with an alternative product.No additional patient consequences have been reported.

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 Description

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

• Brand Name: RIBFIX ADVANTAGE SHORT BRIDGE & 23MM POSTS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10784360
• MDR Text Key: 214523559
• Report Number: 0001032347-2020-00550
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036272319
• UDI-Public: 00841036272319
• Combination Product (y/n): N
• PMA/PMN Number: K141241
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 323.1013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention