MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX ADV LO BRDG & 23MM PST; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/10/2023

Event Type  Injury  

Event Description

It was reported that the surgeon was placed a long bridge into the surgical site and tightened down the washers/caps.He then cut the posts.As he went to plate an adjacent rib, he noticed a post had come through the slot on the plate on the one side.The post was retained by the patient as it could not be removed.The plate was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned bridge assembly.The assembly shows signs of attempted use including marking/ scratching on the bridge surface.One of the two post is missing from the bridge assembly.A review of the track shows that the track is bent which has resulted in the post assembly falling off of the track.The post assembly was not returned.The complaint is confirmed.A determination cannot be made as to what caused the plate assembly to bend resulting in the post to come off of the assembly.Review of the device history records of the subcomponents identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event is confirmed, based on product return.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 is available at the time of this report.

• Brand Name: RIBFIX ADV LO BRDG & 23MM PST
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16894900
• MDR Text Key: 314835541
• Report Number: 0001032347-2023-00155
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• 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
• Device Lot Number: 123272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male