MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRANSDERMAL COMPRESS FAILSAFE TOP PLATE

Model Number N/A

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number - (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was used to complete the procedure.The investigation is in process.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: 0001825034-2018-04359.

Event Description

It was reported the product was packaged without set screws for each side for the patient's legs as the patient is bilateral.The procedure was completed without the set screws.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of device history record.Review of the device history record confirms that no set screws were included in the bill of materials and therefore, not issued to the order.Investigation results concluded that the reported event was due to manufacturing deficiency as the requirements on the print were not properly translated to the bill of materials.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.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.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 available at the time of this report.

• Brand Name: TRANSDERMAL COMPRESS FAILSAFE TOP PLATE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7654373
• MDR Text Key: 113188462
• Report Number: 0001825034-2018-04358
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PCUSTOM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: CP0001031
• Device Lot Number: 081610
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1