MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR 3-IN-1 IMPACTOR; ORTHOPAEDIC IMPLANT IMPACTOR, REUSABLE

Catalog Number	110028055
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was further reported that it is unclear which impactor handle and pad fractured during this procedure.The patient experienced no harm due to the event.No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Visual examination of the provided pictures identified the poly impactor is pictured with a grey tip that is fractured in two fragments and both components are covered in blood.The tip associated with this impactor should be black per print.Additional evaluation of the impactor cannot be completed without product return.Product information confirmed from etch.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Per product design, the pad is attached to the handle with medical grade epoxy and is not designed to be removed as it is approved for effective cleaning and sterilization in its assembled form.Per ifu, 'the majority of surgical instruments and trial prostheses instruments are constructed in such a way that they will not require disassembly.' however, it is unknown if this contributed to the reported event.A definitive root cause cannot 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.

• Brand Name: COMPR 3-IN-1 IMPACTOR
• Common Device Name: ORTHOPAEDIC IMPLANT IMPACTOR, REUSABLE
• 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: 23644561
• Report Number: 0001825034-2025-03779
• Device Sequence Number: 18553401
• Product Code: PHX
• UDI-Device Identifier: 00880304731301
• UDI-Public: (01)00880304731301(11)191220(10)923600
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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
• Device Catalogue Number: 110028055
• Device Lot Number: 923600
• Was Device Available for Evaluation?: No
• 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: 11/20/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPR METAL IMPACTOR CAT#110029132 LOT# 65699399
• Patient Age: 70 YR
• Patient Sex: Female