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

Model Number	N/A
Medical Device Problem Codes	Separation Failure (2547); Material Deformation (2976); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
There is no update to the prior event description provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following section was corrected: d4.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.

• Brand Name: ERGONOMIC HEAD DRIVER
• Common Device Name: 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
• Report Number: 0001825034-2023-02761
• Device Sequence Number: 17709451
• Product Code: LXH
• UDI-Device Identifier: 00887868258589
• UDI-Public: (01)00887868258589(11)220711(10)ZB7212127
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2023
• Supplement Date Received by Manufacturer: 03/18/2024; 02/17/2025
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 03/27/2024; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN TIP
• Patient Sex: Male