MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ERGONOMIC HEAD DRIVER; INSTRUMENT, HIP

Model Number N/A

Device Problems Separation Failure (2547); Material Deformation (2976); Separation Problem (4043)

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

Event Date 11/05/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the head impactor cross threaded so the white tip is unable to be taken off.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.One ergonomic head driver item# 31-399999 lot# zb7212127 was returned and evaluated.Upon visual inspection the white impactor is separated from the black handle but is threaded onto the screw.The impactor cannot be screwed on or off of the handle.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records were not provided.The root cause of the issue is related to off label use of the product as the impactor pad is epoxied on during the manufacturing process and not intended to be removed during the cleaning process.Per ifu this item is not identified within the manual 1258 therefore there should not have been an attempt to remove the impaction pad.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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

There is no update to the prior event description provided.

• Brand Name: ERGONOMIC HEAD DRIVER
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18226511
• MDR Text Key: 329215213
• Report Number: 0001825034-2023-02761
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00887858258589
• UDI-Public: (01)00887858258589(11)220711(10)ZB7212127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: 31-399999
• Device Lot Number: ZB7212127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2022
• 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
• Treatment: UNKNOWN TIP
• Patient Sex: Male