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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).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.

Event Description

It was reported the rib plate malfunctioned and resulted in a retained foreign body during implantation.The surgeon was using the rib plates for repair of multiple rib fractures.The surgeon proceeded to tighten the locking caps and noticed the plate separated from the locking post.This happened to only one of the posts.They were able to unscrew the other side and remove the plate, but couldn't remove the post, cap, and washer on the broken side.The malfunction resulted in a surgical delay that exceeded thirty (30) minutes.It was reported that no further information is available.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Device was not returned for evaluation.No product was returned; therefore, visual and dimensional evaluations could not be performed.Visual examination of the provided pictures identified the plate separated from the post, with components embedded in the tissue.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information 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 LONG BRIDGE & 23MM POSTS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11598979
• MDR Text Key: 246815821
• Report Number: 0001032347-2021-00161
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036272395
• UDI-Public: (01)00841036272395
• Combination Product (y/n): N
• PMA/PMN Number: K141241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• 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: 323.1033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR