MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 3.5MM HEX DRIVE; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

(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

It was reported that the tip of the hex drive broke during a trial assembly.No adverse consequences were reported.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.The following sections were updated/corrected updated: b4, b5, g3, g6, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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: ARCOS 3.5MM HEX DRIVE
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13943497
• MDR Text Key: 288598933
• Report Number: 0001825034-2022-00725
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090757
• 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
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 31-301852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1