MAUDE Adverse Event Report: BIOMET MICROFIXATION ST TRAC TF 24MM BURR HOLE PLT; PLATE, FIXATION, BONE

Catalog Number SP-STA-1021

Device Problem Packaging Problem (3007)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products:: st trac tf 24mm burr hole pltcat# sp-sta-1021 lot# 730290.St trac tf 24mm burr hole pltcat# sp-sta-1021 lot# 730290.Report source: foreign country: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 001032347 - 2021 - 00464, 001032347 - 2021 - 00465.

Event Description

It was reported there was foreign material found within sterile packaging during incoming inspection.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.Quantity of three st trac tf 24mm burr hole plt's were returned for evaluation.Visual examination determined the packaging to be sealed and labeled properly.No failures were found for the devices themselves.However, foreign material was noted within the sterile packages.The part and lot information was verified.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to manufacturing deficiency leading to foreign material in the sterile packaging.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

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

• Brand Name: ST TRAC TF 24MM BURR HOLE PLT
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12540083
• MDR Text Key: 273565521
• Report Number: 0001032347-2021-00466
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SP-STA-1021
• Device Lot Number: 730290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1