MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE LINER IMPACTOR 40MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	00430902800
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while during the surgical procedure the instrument fractured when the nurse mishandled it and the center pin dislocated from the instrument.There was no report of a foreign body retained or harm to the patient.
Additional Manufacturer Narrative
(b)(4).G2: foreign: luxembourg.H2: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.Visual examination of the provided photo identified the reported product with signs of repeated use.However, due to the angle of the photo, further evaluation of the pin could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to user error.The trabecular metal¿ reverse shoulder system surgical technique indicates 'make sure that the guide pin on the poly liner impactor is aligned into the post on the lateral side of the stem face prior to impacting'.Ifu 87-6203-999-23 indicates 'failure to follow these instructions could result in instrument or provisional breakage and potential adverse effects on user(s) or patient.' 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
It was reported that during the surgical procedure, the center pin bent after it was likely impacted incorrectly with a hammer by the surgeon, resulting in misalignment with the liner hole.There was no report of a retained foreign body or patient harm.Due diligence has been completed for this complaint; to date all available additional information has been received.

• Brand Name: TM REVERSE LINER IMPACTOR 40MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23348144
• Report Number: 0001822565-2025-03803
• Device Sequence Number: 9461712
• Product Code: PHX
• UDI-Device Identifier: 00889024267312
• UDI-Public: (01)00889024267312(10)63560365
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 00430902800
• Device Lot Number: 63560365
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2017
• 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: Unknown