MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR METAL IMPACTOR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	110029132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).H3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.H6: component codes: mechanical (g04) - impactor once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that upon completion of the surgical procedure the tip of the instrument was found to be fractured.It was not clear when the tip fractured during the case.There was no foreign body retained or harm to the patient.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.The reported event was confirmed by review of pictures.Visual examination of the provided pictures identified the impactor tip fractured off.Fracture surface is not pictured; therefore, further evaluation cannot be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMPR METAL IMPACTOR
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 22296620
• Report Number: 0001825034-2025-01804
• Device Sequence Number: 12985004
• Product Code: PHX
• UDI-Device Identifier: 00887868470103
• UDI-Public: (01)00887868470103(11)180607(10)782750
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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 Catalogue Number: 110029132
• Device Lot Number: 782750
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Female