MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU 12 HOLE PREBENT PLT; ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE

Catalog Number 76-2602

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ribfix blu 12 hole prebent plt cat# 76-2602 lot#ni.Ribfix blu 8 hole straight plt cat# 76-2601 lot#ni.Multiple mdr reports were filed for this event, please see associated reports: 0001032347 - 2021 - 00410 and 0001032347 - 2021 - 00411.Foreign - event occurred in the united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation, per hospital procedure.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient underwent a revision of three (3) ribfix plates that fractured post initial placement.Plate was used to span a gap which is contra-indicated in the technique.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No products were returned; dimensional evaluations could not be performed.A photo was provided, which shows the three plate immediately after being explanted.All three plates are clearly fractured.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.It was reported that the plate was used to span a gap which is contra-indicated in the technique.This could not be confirmed without medical records, x-rays, or scans.The ifu for these devices says spanning a midline sternotomy is contraindicated and the plate position shall not extend across both costal margins.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 b4, b5, g3, g6, h2, h5, h6 and h10.

Event Description

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

• Brand Name: RIBFIX BLU 12 HOLE PREBENT PLT
• Type of Device: ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12391188
• MDR Text Key: 268898206
• Report Number: 0001032347-2021-00409
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 76-2602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization